FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3ML
MDR report key: 4170847
·
Received October 14, 2014
Report
- Report Number
- 2032227-2014-37858
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE BLOOD GLUCOSE READING WAS 145 MG/DL. THE CUSTOMER'S MOTHER STATED THAT UPON TROUBLESHOOTING, THE INSULIN PUMP PASSED THE SELF TEST. THE ALARM RECURRED DURING A MANUAL PRIME. ADVISED THAT THE ALARM MAY HAVE BEEN CAUSED BY A INFUSION SET OR RESERVOIR OCCLUSION. ADVISED THE CUSTOMER TO REPLACE THE INFUSION SET AND RESERVOIR AS SOON AS POSSIBLE. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648935 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |