MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S RH+K TYPE

Catalog Number	806195100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial and final report on this incident.
Event or Problem Description
The customer reported that a patient sample showed a false positive antibody screening reaction when tested with erytype s rh+k type on tango infinity whereas a sample of the patient tested with erytype s rh+ k-type on march, 09 yielded negative test results.Because of the positive test results on erytype s the customer typed the patient sample for e and c antigen by using the tube technique and yielded negative test results.Due to the current positive antibody screening test the customer assumed that the patient has been transfused.The customer did return the patient sample that had caused a false positive reaction an did return the supposedly defective product for investigational testing.When our quality control received the complaint sample the shelf life of the supposedly defective product was already expired.Nevertheless our quality control laboratory tested the patient sample with the complaint product of erytype rh+k type on tango infinity.The patient sample yielded a weak positive reaction with anti-c on erytype s rh+k type.The patient sample was also tested with our retention sample and the current lot of erytype s rh+k type.The patient sample showed a weak positive reaction with anti-c of both erytype s rh + k type tests.In addition the patient sample was tested for rh phenotype by using the gel card method.The patient sample yielded positive reactions (double population) with anti-c and anti-e.All positive reactions observed by the customer must be interpreted as correct positive reactions due to the transfusion of the patient.The detection of anti-e and anti-c in the patient sample are a strong indicator that the patient has been transfused with e and c positive red blood cells.These transfused red blood cells were detected with the sensitive method of erytype on tango infinity.Testing of different donor samples with the supposedly defective product (within its shelflife) showed that all positive and negative results were correct and we did not observe any false positive results.The testing by our quality control laboratory confirmed that the allegedly defective lot of erytype rh+k type 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 checked by our field service engineers with no indication for a malfunction.The instrument is confirmed to run within specifications.

• Brand Name: ERYTYPE S RH+K TYPE
• Common Device Name: ERYTYPE S RH+K TYPE
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7453912
• Report Number: 9610824-2018-00021
• Device Sequence Number: 16462038
• Product Code: KSZ
• UDI-Device Identifier: 07611969951291
• UDI-Public: (01)07611969951291(17)180401(10)8640050
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK080013
• 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): 04/24/2018

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: 04/01/2018
• Device Catalogue Number: 806195100
• Device Lot Number: 8640050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1