FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 201984
·
Received December 9, 1998
Report
- Report Number
- 2939301-1998-00260
- Event Type
- Malfunction
- Date Received
- December 9, 1998
- Report Date
- September 7, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT HER MOTHER HAD RECEIVED THE ERL MESSAGE. SHE BORROWED THE NEIGHBOR'S METER TO RETEST, THE RESULT WAS REPORTEDLY IN A NORMAL RANGE FOR HER. THE REPORTER'S SON, WHO WAS NOT A KNOWN DIABETIC, USED THE METER AND RECEIVED A ERL. HE WAS TAKEN TO THE HOSPITAL AND THE HOSPITAL BLOOD GLUCOSE LAB RESULT WAS 800MG/DL, HOWEVER THERE WAS NO ALLEGATION OF HARM.
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 | 72 YR |