MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM; ERYTYPE S ABO CONFIRM

Catalog Number	806130100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false positive reaction of a donor sample with anti-b of erytype s abo confirm when used on tango infinity.The customer stated that the donor unit had been typed as blood group a and the sample was processed after a patient sample with blood group b.The customer returned the supposedly defective product for investigational testing and also the patient sample as well as the donor sample.Testing in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Event or Problem Description
The customer reported a false positive reaction of a donor sample with anti-b of erytype s abo confirm when used on tango infinity.The customer stated that the donor unit had been typed as blood group a and the sample was processed after a patient sample with blood group b.The customer was wondering if the patient sample could have affected the donor sample.The customer returned the supposedly defective product for investigational testing as well as the patient sample and the donor sample.Our quality control laboratory tested the complaint sample erytype s abo confirm on tango infinity with different internal patient samples and the samples provided by the customer (patient and donor).All positive and negative results were correct.Additional tests were carried out in order to rule out that the patient sample could have affected the donor sample.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 a field service engineer and found to work within specifications.Customer controls are passing, and there are no hardware errors.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM
• Common Device Name: ERYTYPE S ABO CONFIRM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7585711
• Report Number: 9610824-2018-00028
• Device Sequence Number: 11279398
• Product Code: KSZ
• UDI-Device Identifier: 07611969965670
• UDI-Public: (01)07611969965670(17)181223(10)8726110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/18/2018

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: Health Professional
• Device Expiration Date: 12/23/2018
• Device Catalogue Number: 806130100
• Device Lot Number: 8726110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO INFINITY, # 4230000157; TANGO INFINITY, # 4230000157