FDA Adverse Event
Injury
Summary report: N
LANCET DEVICE MMT-385 SILSRTR EA 13L
MDR report key: 2190391
·
Received July 28, 2011
Report
- Report Number
- 2032227-2011-01850
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 13, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- KZH
- PMA / PMN Number
- K010377
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS STATED THAT THE CUSTOMER WAS IN THE HOSP DUE TO DIABETIC KETOACIDOSIS, AND NEEDED A REPLACEMENT INSERTION DEVICE. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANCET DEVICE MMT-385 SILSRTR EA 13L | ACCESSORIES | KZH | MEDTRONIC MINIMED | MMT-385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |