FDA Adverse Event
Injury
Summary report: N
630G INSULIN PUMP MMT-1715K 630G BLACK MG
MDR report key: 7780445
·
Received August 14, 2018
Report
- Report Number
- 2032227-2018-12996
- Event Type
- Injury
- Date Received
- August 14, 2018
- Date of Event
- July 13, 2018
- Report Date
- August 14, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 00643169656840
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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. 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
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 418 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR SENSOR ANOMALY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: SENSOR ENLITE3 5PK US (OZO) MMT-7008 A-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623290 | 630G INSULIN PUMP MMT-1715K 630G BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715K | HG25601 | 00643169656840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other |