FDA Adverse Event
Malfunction
Summary report: N
010-411-014 UNK
MDR report key: 199743
·
Received November 23, 1998
Report
- Report Number
- 2939301-1998-00943
- Event Type
- Malfunction
- Date Received
- November 23, 1998
- Report Date
- October 5, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER EXPERIENCED THE ER1 MESSAGE, RETESTED AND REC'D A RESULT BETWEEN 90-140. HE DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK MEDICAL ADVICE/TREATMENT FROM A HEALTHCARE PROVIDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 010-411-014 UNK | * | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |