MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for LIFECODES HLA DQAB 3006951 200210-50 manufactured by Immucor Gti Diagnostics, Inc..
[141486634]
Sample (b)(6): discordant dqa. Ssp results: dqa1*01:03 dqa1*02:01. Lifecodes sso result: dqa1*01:xx dqa1*01:xx. Probe 207 assignment (52% below cut-off) would have to be changed to positive for result to be concordant with ssp. Batch shows no evidence of contamination. Customer also reports incorrect sso result with sample (b)(6). Raw data requested. Laboratory visit confirms that all testing is performed according to instructions listed in ifu for product. And customer is using verity cycler for amplification and hybridization steps of protocol. Laboratory visit confirms that match it dna software has (b)(6) database applied. Sso results for dqab for these samples were not reported.
Patient Sequence No: 1, Text Type: N, H10
[141486635]
Customer reports incorrect result with samples tested with lifecodes dqab sso lot 3006951. Customer reports 2 samples gave results discordant with ssp sample (b)(6): discordant dqa. Ssp results: dqa1*01:03 dqa1*02:01. Lifecodes sso result: dqa1*01:xx dqa1*01:xx. Probe 207 assignment (52% below cut-off) would have to be changed to positive for result to be concordant with ssp. Batch shows no evidence of contamination. Customer also reports incorrect sso result with sample (b)(6). Raw data requested. Laboratory visit confirms that all testing is performed according to instructions listed in ifu for product. And customer is using verity cycler for amplification and hybridization steps of protocol. Laboratory visit confirms that match it dna software has (b)(6) database applied. Sso results for dqab for these samples were not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2019-00001 |
| MDR Report Key | 8373640 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2017-12-15 |
| Date Added to Maude | 2019-02-27 |
| 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 ROBERT VOIGTS |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541026 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIFECODES HLA DQAB |
| Generic Name | HLA DQAB |
| Product Code | MZI |
| Date Received | 2019-02-27 |
| Returned To Mfg | 2019-02-26 |
| Model Number | 3006951 |
| Catalog Number | 200210-50 |
| Lot Number | 3006951 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-27 |