FDA Adverse Event
Malfunction
Summary report: N
LANCET DEVICE
MDR report key: 4021880
·
Received August 19, 2014
Report
- Report Number
- 2032227-2014-09691
- Event Type
- Malfunction
- Date Received
- August 19, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
RELIABILITY ANALYSIS INSPECTED 1 OPENED/USED ENLITE SERTER AND PERFORMED INSTRUCTION TEST USING A NEW LAB. ENLITE SENSOR ALONG WITH RUBBER SKIN (IFU) 6025427-23A-B ENLITE SERTER PASSED PER SPEC. INSERT/RELEASE SENSOR PROPERLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A SENSOR AND INSERTER ISSUE. THE BLOOD GLUCOSE READING WAS 83 MG/DL. PRIOR TO THE EVENT, THE PATIENT REPORTED THAT THE NEEDLE HUB WAS STUCK IN THE SERTER. THE CUSTOMER WAS ADVISED TO NOT PUSH TOO HARD INTO THE BODY BETWEEN BUTTON PRESSES. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498004 | LANCET DEVICE | CGM | MDS | MEDTRONIC MINIMED | MMT-7510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |