MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2008-09-26 for CAPTURE-R SELECT manufactured by Immucor, Inc..
[963050]
Customer reported dat tests for patient samples tested had an increased rate of a false negative results using capture-r (cr) select. They tested 32 baby samples parallel in on galileo, tube and bio-vue system. Six samples showed a negative result in cr select tested on galileo, but tube test and bio-vue system showed positive results (1 - 2+).
Patient Sequence No: 1, Text Type: D, B5
[8097458]
The instrument was evaluated; no technical errors were observed. No product deficiency was observed. The customer did not return product or sample for investigation testing. It is not possible to rule out the sample as a cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2008-00471 |
| MDR Report Key | 1174343 |
| Report Source | 01,05,06,08 |
| Date Received | 2008-09-26 |
| Date of Report | 2008-09-23 |
| Date of Event | 2008-09-01 |
| Date Mfgr Received | 2008-09-01 |
| Date Added to Maude | 2008-10-06 |
| 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 | 3 |
| 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 | 2008-09-26 |
| Lot Number | SC090 |
| Device Expiration Date | 2008-11-05 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1201297 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-26 |