MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for CSW100 WASHING SYSTEM 0005175 manufactured by Immucor, Inc..
[25140747]
We are unable to rule out the issue being related to the technique and or handling of the testing on the manual capture by the customer.
Patient Sequence No: 1, Text Type: N, H10
[25140788]
Customer reported obtaining unexpected negative (compatible) crossmatch results for a patient sample containing anti-jkb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2015-00130 |
| MDR Report Key | 5057819 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2009-12-31 |
| Date Added to Maude | 2015-09-04 |
| 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 | CSW100 WASHING SYSTEM |
| Generic Name | MICROPLATE WASHER |
| Product Code | JQW |
| Date Received | 2015-09-04 |
| Catalog Number | 0005175 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2015-09-04 |