MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-04 for FMH RAPIDSCREEN 0007893 manufactured by Immucor, Inc..
[4733678]
On (b)(6) 2014, a customer reported an unexpected negative result when using fmh rapidscreen.
Patient Sequence No: 1, Text Type: D, B5
[12299789]
Immucor laboratory received returned sample (b)(4) on (b)(4) 2014, however was unable to test it because it was beyond the prescribed usability dates. The immucor laboratory did however test retention fmh rapidscreen product which performed as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2014-00163 |
| MDR Report Key | 4060889 |
| Report Source | 05,06 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-08-08 |
| Date Mfgr Received | 2014-08-08 |
| Date Added to Maude | 2014-09-17 |
| 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 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 30091562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 5625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FMH RAPIDSCREEN |
| Generic Name | TEST, SCREENING, FOR D POSITIVE FETAL RBC'S |
| Product Code | LIM |
| Date Received | 2014-09-04 |
| Catalog Number | 0007893 |
| Lot Number | 24516 |
| Device Expiration Date | 2014-08-22 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091562 US 30091 5625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-04 |