MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2009-01-07 for CAPTURE R SELECT manufactured by Immucor, Inc..
[1021186]
Customer reported that the echo was giving false positive weak-d results for negative patient samples, using capture r select strips.
Patient Sequence No: 1, Text Type: D, B5
[8170738]
Verified at the cusotmer site, that the pouch for capture r select strips was not well closed. Retesting with strips from the same pouch gave the same results. Testing with strips from a new pouch gave the correct results. Instructed the technician how to correctly preserve the strips.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2009-00002 |
| MDR Report Key | 1278683 |
| Report Source | 01,05,06 |
| Date Received | 2009-01-07 |
| Date of Report | 2009-01-05 |
| Date of Event | 2008-12-08 |
| Date Mfgr Received | 2008-12-08 |
| Date Added to Maude | 2009-04-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. J. SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE R SELECT |
| Generic Name | BLOOD BANK SUPPLIES |
| Product Code | KSS |
| Date Received | 2009-01-07 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-07 |