FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-507CRUB EA INSULIN BL EN US RC
MDR report key: 1062770
·
Received June 16, 2008
Report
- Report Number
- 2032227-2008-00990
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- May 29, 2008
- Report Date
- May 12, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K972107
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD A MISSING CLIP ON THE DRIVER BLOCK. UNABLE TO PERFORM THE OCCLUSION TEST DUE TO THE DRIVE ANOMALY.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT NO DELIVERY ALARMS DURING THE BASAL RATE DELIVERY. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE LEADSCREW TEST. ADVISED THE CUSTOMER TO REVERT TO A BACK-UP PLAN AS THE INSULIN PUMP NEEDED TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-507CRUB EA INSULIN BL EN US RC | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-507CRUB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |