FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2830873
·
Received November 13, 2012
Report
- Report Number
- 3004209178-2012-90726
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- September 21, 2012
- Report Date
- October 30, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS INSULIN PUMP ALARMED DURING THE REWIND PROCESS. THE CALLER STATED THAT THE DEVICE ALSO ALARMED WHEN THE RESERVOIR WAS LOW AND THEN AGAIN WHEN IT WAS PRIMING. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. THE BLOOD GLUCOSE READING WAS 114MG/DL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | OYC | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |