MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-07-25 for LIFECODES HLA-DQA1/B1 SSO TYPING KIT 628930 manufactured by Immucor Gti Diagnostics, Inc..
[115468181]
Customer complaint ((b)(4)) was received 02may2017 via product distributor that customer is having issues with lifecodes hla-dqa1b1 sso typing kit (628930), lot 10205a. Customer reports that multiple indeterminate probes (weak reactivity), specifically beads 242, 274, 281, and 292 are noted as falling below the lot specific cut-off value. Per the product ifu, 2 probes may be indeterminate (falling below the lot specific cut-off value). For this assay, 4 probes were indeterminate, therefore invalidating the assay. It is not known if the customer recognized that this assay was invalid due to the 4 probes resulting as indeterminate. The customer performs the assay with several variations from the protocol described in the lifecodes hla-dqa1b1 sso typing kit ifu (instructions for use). Alternate method to prepare sample volume used in the assay, dna concentration is not quantified it is expected the range they use meets the assay defined range, alternate vendor amplification plates are used. Data provided by the customer points to issues with technique/equipment and not with kit. Additional questions asked of customer were not responded to. Root cause of weakly reactive probes in lifecodes dqab sso kit could not be determined from information received from distributor. Continued monitoring will be done. No further actions are required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00020 |
| MDR Report Key | 7720742 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-07-25 |
| Date of Report | 2017-04-26 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2015-12-22 |
| Date Added to Maude | 2018-07-25 |
| 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 HLA-DQA1/B1 SSO TYPING KIT |
| Generic Name | LIFECODES HLA-DQA1/B1 SSO TYPING KIT |
| Product Code | MZI |
| Date Received | 2018-07-25 |
| Catalog Number | 628930 |
| Lot Number | 10205A |
| Device Expiration Date | 2017-06-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-25 |