640G INSULIN PUMP

Report

• Report Number: 2032227-2016-53148
• Event Type: Malfunction
• Date Received: December 23, 2016
• Date of Event: November 30, 2016
• Report Date: June 1, 2022
• Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
• Product Code: OYC
• Removal / Correction Number: Z-0958-2020
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: GM
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0958-2020. 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.

Additional Manufacturer Narrative · 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

Additional Manufacturer Narrative · 1

THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR AND DISPLACEMENT TESTS. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM OR NO DELIVERY ALARM NOTED. THE PUMP WAS RECEIVED WITH A MISSING LCD WINDOW COVER AND A CRACKED RESERVOIR RETAINER.

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP EXCESSIVELY ALARMED NO DELIVERY DURING BOLUS AND FIXED PRIME. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING FOUND THAT THE ALARMS DID NOT CLEAR AFTER THE PUMP WENT THROUGH TROUBLESHOOTING.THE CUSTOMER WAS DVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS. THERE WAS NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER OR BY TROUBLESHOOTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
852968	640G INSULIN PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-1712K

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 3

• Device Displays Incorrect Message
• Failure to Deliver
• Visual Prompts will not Clear

Remedial action · 1

• Recall

Source type · 2

• Company representation
• Foreign

Type of report · 2

• Followup
• Initial submission