MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-29 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[53442231]
Customer complaint ((b)(4)) received for failed run with donorscreen-hla class i and class ii assay (dsi+ii) lot 3002728a for assay run on (b)(6) 2016. Technical support reviewed customer's data from the failed assay and determined that negative serum control-class i value (0. 176) did not meet quality control criteria. According to the instructions for use (ifu), donorscreen-hla class i assay control requirements are mean of pc >= 1. 500 and mean of nc >= 0. 040 and <= 0. 150. Customer confirmed that staff runs full plates. Failed assay would result in customer having to repeat testing, so there is no harm to patient but rather a delay in results. This failure mode, where increased negative serum control-class i value resulted in invalid assay, was identified during investigation for a prior complaint ((b)(4)) for donorscreen-hla lot 3002728a. Investigation for (b)(4) confirmed that only full plates with lot 3002728a exhibited this failure. A field action (market withdrawal; immucor gti diagnostics inc. Internal #(b)(4)) was initiated on 07-28-2016, for donorscreen-hla assay lot 3002728a and the additional reagents packaging lot 3002728b, due to product malfunction. Us fda was notified of the field action on 07-28-2016. Email response was received from fda on 08-02-2016 evaluating the field action as market withdrawal, with no additional reporting required. An mdr (mfr report # 2183608-2016-00003) was submitted to us fda on 08-04-2016, for complaint (b)(4). (b)(4) has been initiated to correct and prevent recurrence of this issue. Customer was asked to discard remaining kits of donorscreen-hla lot 3002728a/b. Customer reported that they discontinued using the lot and did not report results due to assay failure. Customer was sent 2 replacement kits, as requested.
Patient Sequence No: 1, Text Type: D, B5
[55158043]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2016-00004 |
| MDR Report Key | 5912783 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-06-28 |
| Date Mfgr Received | 2016-08-01 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2016-08-29 |
| 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 | MS. PADMINI SAHOO |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541005 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | INTERNAL # FA-17-01 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONORSCREEN-HLA CLASS I AND CLASS II |
| Generic Name | DONORSCREEN-HLA CLASS I AND CLASS II ASSAY |
| Product Code | MZI |
| Date Received | 2016-08-29 |
| Model Number | NA |
| Catalog Number | DSI+II |
| Lot Number | 3002728A |
| Device Expiration Date | 2017-04-15 |
| Device Availability | N |
| Device Age | DA |
| 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 531864054 US 531864054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |