FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 236920
·
Received August 17, 1999
Report
- Report Number
- 2939301-1999-00627
- Event Type
- Malfunction
- Date Received
- August 17, 1999
- Report Date
- July 18, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE RPTR STATED THAT HE DID BACK TO BACK BLOOD GLUCOSE TESTING, WITHIN 5 MINS, USING DIFFERENT FINGER STICKS. HE REPORTED RESULTS OF 232, 192 AND 166 MG/DL. HE DID NOT HAVE ANY SYMPTOMS. ON FOLLOWUP, HE RELATED THAT HIS METER AND STRIPS HAD BEEN STORED IN 95-110 DEGREE TEMPERATURES. THE LIFESCAN REP REVIEWED QC, STRIP STORAGE, AND METER/LAB TESTING WITH THE RPTR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE MONITORING SYSTEM/KIT | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |