FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 225097
·
Received May 21, 1999
Report
- Report Number
- 2939301-1999-00381
- Event Type
- Malfunction
- Date Received
- May 21, 1999
- Report Date
- April 21, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, NO MORE THAN 3 MINUTES APART, USING SEPARATE FINGERSTICKS. RPTR STATED THAT HER RESULTS WERE 160, 102, AND 131 MG/DL. DURING TROUBLESHOOTING, THE RPTR CLEANED HER TEST STRIP HOLDER, RETESTED WITH RESULTS OF 102 AND 83 MG/DL, AND ALSO LEARNED HOW TO USE THE COLOR CHART. THE RPTR STATED THAT SHE DID NOT HAVE ANY SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE METER | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |