FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522WWL PRDGM INSULIN CL EN ML
MDR report key: 1212700
·
Received October 22, 2008
Report
- Report Number
- 3004209178-2008-00861
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 7, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CUSTOMER PROGRAMS A BOLUS, THE DELIVERY IS NOT CONSISTENT WHEN OBSERVED AT THE CANNULA OF THE INFUSION SET. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522WWL PRDGM INSULIN CL EN ML | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |