MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-31 for LIFECODES CLASS I ID 628200 manufactured by Immucor Gti Diagnostics, Inc..
[115650267]
Complaint (b)(4) for lifecodes class i id (628200), lot # 3006385 was received on july 6, 2018. The customer reports pattern of positive results for historically negative patients when tested with class i id lot 3006385. The lab's sop requires that all samples are pre-treated with dtt (dithiothreitol) prior to testing. Customer has been informed that pre-treatment with dtt is not a validated process and is considered off-label use. Immucor technical support requested the customer run the samples neat (without pre-treatment). Customer stated that they will not perform any trouble-shooting at this time but would like immucor to address this issue in their manufacturing processes. Customer confirms no patient harm. Customer reported the results because the assay is not used as a standalone test. Significant changes in reactivity are verified by an alternate assay. Review of final product quality control (fpqc) testing was performed, product specifications were met.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00027 |
| MDR Report Key | 7736238 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2018-07-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE EWEND |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541009 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECODES CLASS I ID |
| Generic Name | LIFECODES CLASS I ID |
| Product Code | MZI |
| Date Received | 2018-07-31 |
| Catalog Number | 628200 |
| Lot Number | 3006385 |
| Device Expiration Date | 2019-01-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |