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

Catalog Number 806 195 100

Device Problems False Positive Result (1227); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that a patient sample showed a false positive reaction when tested with anti-c on erytype s rh+k type on tango optimo.The customer did return a sample of the allegedly defective product for further investigation and also the patient sample that had caused a false positive test result.Testing in our quality control laboratory is still ongoing.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that a patient sample showed a false positive reaction when tested with anti-c on erytype s rh+k type on tango optimo.The customer did return a sample of the allegedly defective product for further investigation and also the patient sample that had caused the false positive test result.Our quality control laboratory retested the patient sample with the provided sample of erytype s rh+k type and could confirm the customer's result.The patient sample yielded a clearly positive reaction with anti-c on erytype.The patient sample was also tested in the tube technique with different monoclonal and polyclonal anti-c reagents and also in the gel method.The patient sample showed clear positive reactions with all used reagents.Due to these test results the positive test result with erytype seems to be a correct positive result.Because the provided patient sample was a donor segment and therefore not suited for molecular typing, molecular typing for rhesus c antigen could not be performed.The supposedly defective lot was tested with different samples.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 erytype s 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.

• Brand Name: ERYTYPE S RH+K TYPE
• Type of Device: ERYTYPE S RH+K TYPE
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 103 313057
• MDR Report Key: 5483035
• MDR Text Key: 40137950
• Report Number: 9610824-2016-00009
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2016
• Device Catalogue Number: 806 195 100
• Device Lot Number: 8448090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1