PUMP MMT-1880L MM770G BLE MG
Report
- Report Number
- 2032227-2022-343920
- Event Type
- Malfunction
- Date Received
- September 29, 2022
- Date of Event
- May 23, 2022
- Report Date
- October 6, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000439866
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. RETAINER RING = BLACK. THE CUSTOMER RETURNED THE PUMP FOR ALLEGED INSULIN FLOW BLOCK ALARM, HIGH BLOOD GLUCOSE AND PRIME ANOMALY ON MAY 22, 2022. ON SVN 000314300197 THE CUSTOMER RETURNED THE PUMP FOR ALLEGED INSULIN FLOW BLOCK ALARM ON MAY 22, 2022. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0874 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE PUMP RECOGNIZED THE WATER FILLED RESERVOIR THAT WAS INSTALLED IN THE RESERVOIR COMPARTMENT. THE PUMP WAS PROGRAMMED WITH A 2.0 UNIT FILL CANNULA DELIVERY. THEN THE PUMP DELIVERED THE 2.0 UNITS PROPERLY WITH WATER EXITING THE INFUSION SET. NO PRIME/FILL ANOMALY OR PRIME/SEATING ANOMALY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. PLEASE SEE BELOW FOR THE NO DELIVERY ALARM LISTED ON THE EVENT DATE IN THE PUMP HISTORY FILE. MAY 23, 2022 06:17:49.000 ALARMALERTNOTIFICATION (40) FAULT NUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 07:18:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 07:22:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 08:11:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 08:21:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 09:53:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 11:08:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 11:13:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 12:14:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 12:23:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 12:28:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 12:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 13:43:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 13:48:40.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 13:53:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 13:58:37.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 14:03:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 14:14:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING PRIME MAY 23, 2022 14:26:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 14:30:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 14:36:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASAL MAY 23, 2022 15:11:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 20:53:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 20:53:37.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 22:22:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 22:23:38.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 23, 2022 23:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS PLEASE SEE BELOW FOR THE NO DELIVERY ALARM LISTED ON THE EVENT DATE MAY 22, 2022 FOR SVN 000314300197 IN THE PUMP HISTORY FILE. MAY 22, 2022 00:34:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASALMAY 22, 202200:44:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BASA MAY 22, 2022 20:18:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS MAY 22, 2022 22:22:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS 05/22/2022MAY 22, 2022 22:23:20.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) - DURING BOLUS. THE PUMP PASSED THE FUNCTIONAL TESTING. THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS NOT CONFIRMED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. UNABLE TO CONFIRM ALLEGED HIGH BLOOD GLUCOSE. PRIME/FILL ANOMALY OR PRIME/SEATING ANOMALY WAS NOT CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(4). THE CUSTOMER RETURNED THE INSULIN PUMP FOR ALLEGED INSULIN FLOW BLOCK ALARM, HIGH BLOOD GLUCOSE S AND PRIME ANOMALY ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER RETURNED THE PUMP FOR ALLEGED INSULIN FLOW BLOCK ALARM ON (B)(6) 2022.THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0874 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE PUMP RECOGNIZED THE WATER FILLED RESERVOIR THAT WAS INSTALLED IN THE RESERVOIR COMPARTMENT. THE PUMP WAS PROGRAMMED WITH A 2.0 UNIT FILL CANNULA DELIVERY. THEN THE PUMP DELIVERED THE 2.0 UNITS PROPERLY WITH WATER EXITING THE INFUSION SET. NO PRIME/FILL ANOMALY OR PRIME/SEATING ANOMALY NOTED.THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP.THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING. THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS NOT CONFIRMED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. UNABLE TO CONFIRM ALLEGED HIGH BG'S.PRIME/FILL ANOMALY OR PRIME/SEATING ANOMALY WAS NOT CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED INSULIN FLOW BLOCK ALARM. INSULIN EXITED AFTER TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747136 | PUMP MMT-1880L MM770G BLE MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1880L | HG674U7 | 000000763000439866 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male |