MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-04-13 for CAPTURE-S * manufactured by Immucor, Inc..
[736735]
Customer reported unexpected negative reactions with capture-s indicator cells, lot 229018. Capture s positive controls were not working on the dias or the galileo, the controls ran twice on the dias and three times on the galileo. Repeat testing was performed with the same positive control (lot 250149) and a new vial of indicator (lot 229029) but the positive control failed again.
Patient Sequence No: 1, Text Type: D, B5
[7880053]
Testing was performed with retention capture-s indicator cells (csic), lots 229027, 229028, and 229029, using cs reactive control serum, and cs nonreactive control serum. With csic, lot 229027, the reactive controls exhibited weak to moderate reactivity. With csic, lot 229028, very weak to weak reactivity was observed, and with csic, lot 229029, all reactions were negative, with some fuzzy buttons observed. Testing was performed on an in-house galileo using csic, lots 229028 and 229029 using cs reactive control serum. Three test runs were performed using different combinations of csic and reactive controls. All runs were invalid due to failure of controls to meet cut-off reactivity. Csic, lots 229028 and 229029 were investigated and raw material was determined as the root cause of the weakened reactivity seen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2007-00068 |
| MDR Report Key | 939471 |
| Report Source | 06 |
| Date Received | 2007-04-13 |
| Date of Report | 2007-04-13 |
| Date of Event | 2007-03-13 |
| Date Mfgr Received | 2007-03-13 |
| Date Added to Maude | 2007-11-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | J. SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | FA-06-12 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-S |
| Generic Name | GMQ |
| Product Code | GMQ |
| Date Received | 2007-04-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 229028 |
| ID Number | * |
| Device Expiration Date | 2006-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 911721 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | * NORCROSS GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-13 |