MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for CAPTURE-P 0066246 manufactured by Immucor, Inc..
[55670624]
The capture-p process is a manual user process. Immucor technical support used phone support. No blood sample or customer site product was returned to immucor for investigation. The customer commented that the member of staff performing the original manual testing was a trainee and the customer determined that they had made a user sample addition error. Manual user process with phone support.
Patient Sequence No: 1, Text Type: N, H10
[55670625]
On (b)(6) 2016, a customer site reported ten (10) unexpected negative platelet crossmatch tests when tested against one single blood sample, when using capture-p.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2016-00244 |
| MDR Report Key | 5966769 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-09-21 |
| 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 | 3 |
| Manufacturer Contact | MR HOWARD YOREK |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTURE-P |
| Generic Name | SOLID PHASE SYSTEM FOR THE DETECTION OF IGG ANTIBODIES TO PLATELETS |
| Product Code | KSS |
| Date Received | 2016-09-21 |
| Catalog Number | 0066246 |
| Lot Number | P171 |
| Device Expiration Date | 2016-12-01 |
| 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 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |