FDA Adverse Event
Malfunction
Summary report: N
SICKLESCREEN SICKLING HB SCREENING KIT
MDR report key: 58317
·
Received December 18, 1996
Report
- Report Number
- 1055411-1996-00002
- Event Type
- Malfunction
- Date Received
- December 18, 1996
- Date of Event
- October 25, 1996
- Report Date
- December 12, 1996
- Manufacturer
- PACIFIC HEMOSTASIS
- Product Code
- GHM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 10/25/96, TWO DISTINCT HOSP LABORATORIES REPORTED THAT 30 DETERMINATION DIAGNOSTIC TEST KIT LOT 250A03 WAS PRODUCING FALSE NEGATIVE RESULTS WITH POSITIVE CONTROLS AND KNOWN POSITIVE PT SPECIMENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SICKLESCREEN SICKLING HB SCREENING KIT | IN VITRO DIAGNOSTIC TEST KIT - QUALITATIVE | GHM | PACIFIC HEMOSTASIS | NA | 250A03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other | NUNBER 10-0251. THE PRODUCT PERFORMANCE DEFECT IS| LABORATORY PROFESSIONALS MONITOR ASSAY RESULTS| OF SUPPLIERS. THE CO'S CONTROL SET IS CATALOG| NOT THE RESULT OF ANY CONTROL DEFECT.| WITH POSITIVE AND NEGATIVE CONTROLS FROM A VARIETY |