MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-09 for CAPTURE-CMV 0066206 manufactured by Immucor, Inc..
[129162816]
(b)(6) was (b)(6) compared to diasoron (b)(4). Sample was discarded by customer and therefore unavailable for further investigations to be able to referee the different outcomes and to definitively determine correct result outcome. On (b)(6) 2018 performed a (b)(4) assay on six samples with known (b)(6) status in manual capture using retention capture cmv plates lot c133 and retention (b)(4) indicators cells lot 228331. Controls performed as expected and all samples resulted as expected. Retention product performed as expected. Immucor cannot rule out the possibility of the specimen being the cause of unexpected (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129162817]
On (b)(6) 2018 a customer reported unexpected (b)(6) results with (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00257 |
| MDR Report Key | 8057064 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-11-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | CAPTURE-CMV |
| Generic Name | CYTOMEGALOVIRUS ANTIBODY SCREEN |
| Product Code | LJO |
| Date Received | 2018-11-09 |
| Catalog Number | 0066206 |
| Lot Number | C133 |
| Device Expiration Date | 2018-11-22 |
| 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 | 1. Congenital Not Applicablenomaly | 2018-11-09 |