MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B

Catalog Number 806127100

Device Problems No Display/Image (1183); False Positive Result (1227); Defective Device (2588)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that she is unable to pass qc because she is seeing globs in the images instead of clearly negative results in the reverse typing when using erytype s abd+rev a1,b on tango optimo.Due to the globs in the reverse typing the reactions were interpreted as positives by the tango optimo when the reactions were supposed to be negative.Due to the discrepancy between forward and reverse typing the tango optimo did not show a blood group and no incorrect results were released.The customer returned the complaint sample of erytype s abd+rev a1,b for further investigation but not the patient samples that had caused false positive test results.Testing in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.The sent result image shows a light red background around a dark red spot in the reverse a1- and b-cell wells.This spot is not a normal agglutination, but looks rather like hemolysis, which has led to discrepant overall result of the ab rh d positive quality control sample.The instrument's software flagged this sample as discrepant and did not give an overall result out.The last bi-annual preventive maintenance was performed on (b)(6) 2018.No log files are present for evaluation as the customer refused to allow access to files.The affected tango optimo was inspected by our field service engineers.They confirmed the issue, and verified the orbital shaker.Sample syringe and valve were replaced, and reagent syringes were replaced as well.The problem continued until on board plates were replaced with new plates.Performed post service verification procedure, as required.Instrument is operating within manufacturer specification and returned to full operation.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that she is unable to pass qc because she is seeing globs in the images instead of clearly negative results in the reverse typing when using erytype s abd+rev a1,b on tango optimo.Due to the globs in the reverse typing the reactions were interpreted as positives by the tango optimo when the reactions were supposed to be negative.Due to the discrepancy between forward and reverse typing the tango optimo did not show a blood group and no incorrect results were released.The customer returned the complaint product sample for further investigation but not the patient samples that had caused false positive test results.Therefore our quality control laboratory tested the four erytype plates submitted by the customer with different donor samples.All positive and negative reactions were correct.We did not observe any globs in the reverse typing.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytypecell a1&b functions correctly.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Result pictures were available and reviewed: the result image shows a light red background around a dark red spot in the reverse a1- and b-cell wells.This spot is not a normal agglutination, but looks rather like hemolysis, which has led to discrepant overall result of the ab rh d positive quality control sample.The instrument's software flagged this sample as discrepant and did not give an overall result out.The last bi-annual preventive maintenance was performed on 09/13/2018.No log files are present for evaluation as the customer refused to allow access to files.The affected tango optimo was inspected by our field service engineers.They confirmed the issue, and verified the orbital shaker.Sample syringe and valve were replaced, and reagent syringes were replaced as well.The problem continued until on board plates were replaced with new plates.Performed post service verification procedure, as required.Instrument is operating within manufacturer specification and returned to full operation.No indication for an instrument malfunction could be identified on current information.Log files and samples were not made available and qc testing showed results as expected.But as stated by the engineer, replacement with other erytype plates resolved the problem.The actions performed during the service intervention may also have contributed to the resolution.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Type of Device: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8234839
• MDR Text Key: 134584212
• Report Number: 9610824-2018-00091
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: 08/25/2019
• Device Catalogue Number: 806127100
• Device Lot Number: 8809190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TANGO OPTIMO, # 9142400478; TANGO OPTIMO, # 9142400478