MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-CMV; CYTOMEGALOVIRUS ANTIBODY SCREEN

Catalog Number	0066206
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) was (b)(6) compared to diasoron (b)(4).Sample was discarded by customer and therefore unavailable for further investigations to be able to referee the different outcomes and to definitively determine correct result outcome.On (b)(6) 2018 performed a (b)(4) assay on six samples with known (b)(6) status in manual capture using retention capture cmv plates lot c133 and retention (b)(4) indicators cells lot 228331.Controls performed as expected and all samples resulted as expected.Retention product performed as expected.Immucor cannot rule out the possibility of the specimen being the cause of unexpected (b)(6).(b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported unexpected (b)(6) results with (b)(6).

• Brand Name: CAPTURE-CMV
• Common Device Name: CYTOMEGALOVIRUS ANTIBODY SCREEN
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8057064
• Report Number: 1034569-2018-00257
• Device Sequence Number: 16503332
• Product Code: LJO
• UDI-Device Identifier: 10888234001157
• UDI-Public: 10888234001157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: 0066206
• Device Lot Number: C133
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Age: 39 YR