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 10-0250 manufactured by Pacific Hemostatis.
[17903805]
On 10/31/96, a hosp lab reported that 30 determination diagnostic test kit lot 260a03 was producing false negative results with positive controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055411-1996-00004 |
| MDR Report Key | 59018 |
| Report Source | 05,06 |
| Date Received | 1996-12-18 |
| Date of Report | 1996-12-12 |
| Date of Event | 1996-10-31 |
| Date Mfgr Received | 1996-10-31 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-01-02 |
| 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 | RL |
| 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 | 10-0250 |
| Lot Number | 250A03 |
| ID Number | FISHER CATALOG# 22251050 |
| Device Expiration Date | 1998-09-30 |
| 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 | 59451 |
| Manufacturer | PACIFIC HEMOSTATIS |
| Manufacturer Address | 11515 VANSTORY DRIVE HUNTERSVILLE NC 28078 US |
| Baseline Brand Name | SICKLESCREEN |
| Baseline Generic Name | SICKLING HEMOGLOBIN SCREENING KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 10-0250 |
| Baseline ID | FISHER CATALOG |
| Baseline Device Family | SICKLESCREEN SICKLING HEMOGLOBIN SCREENING KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K854079 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-18 |