MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B; ERYTYPECELL A1 & B, 2X10 ML

Catalog Number	816056100
Health Effect - Clinical Codes	Reaction (2414); Test Result (2695)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported false positive results of the serum grouping reagent red blood cells ery type cell a1 and b on tango infinity.The customer stated that negative reverse grouping images were identified as +/- by the instrument.The customer returned neither the specimen that had caused false positive test results for investigational testing nor the supposedly defective product.Therefore our quality control laboratory tested their retention sample of ery type cell a1 and b with different samples on tango infinity.All positive and negative reactions were correct.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of ery type cell a1 and b functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango infinity was inspected by one of our field service engineers with no indication for an instrument malfunction.The service engineer confirmed a proper function of the instrument by metrology qualification.

• Brand Name: ERYTYPECELL A1 & B
• Common Device Name: ERYTYPECELL A1 & B, 2X10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7005458
• Report Number: 9610824-2017-00080
• Device Sequence Number: 13652896
• Product Code: KSZ
• UDI-Device Identifier: 07611969952656
• UDI-Public: 07611969952656
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: Health Professional
• Device Expiration Date: 10/23/2017
• Device Catalogue Number: 816056100
• Device Lot Number: 8735011-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1