MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-12-18 for SICKLESCREEN SICKLING HB SCREENING KIT SEE PAGE 3 manufactured by Pacific Hemostasis.
[37212]
On 10/28/96, a hosp laboratory reported that 30 determination diagnostic test. Kit lot 250a03 was producing false negative results with positive controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055411-1996-00003 |
| MDR Report Key | 58547 |
| Report Source | 05,06 |
| Date Received | 1996-12-18 |
| Date of Report | 1996-12-12 |
| Date of Event | 1996-10-28 |
| Date Mfgr Received | 1996-10-28 |
| Date Added to Maude | 1996-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SICKLESCREEN SICKLING HB SCREENING KIT |
| Generic Name | IN VITRO DIAGNOSTIC TEST KIT-QUALITATIVE |
| Product Code | GHM |
| Date Received | 1996-12-18 |
| Model Number | NA |
| Catalog Number | SEE PAGE 3 |
| Lot Number | SEE PAGE 3 |
| ID Number | SEE PAGE 3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58999 |
| Manufacturer | PACIFIC HEMOSTASIS |
| Manufacturer Address | 11515 VANSTORY DRIVE HUNTERSVILLE NC 28078 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-18 |