FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM PLASMA TEST STRIPS
MDR report key: 964660
·
Received December 10, 2007
Report
- Report Number
- 1823260-2007-10618
- Event Type
- Malfunction
- Date Received
- December 10, 2007
- Date of Event
- October 4, 2007
- Report Date
- December 10, 2007
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN THE NETHERLANDS.
Description of Event or Problem · 1
RPTR STATED THAT A NEONATE'S BLOOD GLUCOSE WAS TESTED, USING THE INFORM SYS, WITH A RESULT OF 4.1 MMOL/L. AN ADD'L SAMPLE WAS IMMEDIATELY OBTAINED FROM THE NEONATE AND, WHEN TESTED IN THE FACILITY'S LAB, MEASURED 2.9 MMOL/L. RPTR DID NOT INDICATE IF PT WAS TREATED BASED ON THE VALUE OBTAINED ON THE INFORM SYS. NO ADVERSE EVENT WAS REPORTED. THE MFR REQUESTED THE RETURN OF THE SUSPECT PROD FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK INFORM PLASMA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - NA | NBW | ROCHE DIAGNOSTICS CORP. | 549753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |