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

Catalog Number 806127100

Device Problem False Positive Result (1227)

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

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that two patient samples yielded false positive results with the anti-d reagents of erytype s abd+rev.A1, b when used on tango infinity.The samples gave an rh negative result when tested manually.The customer returned three patient samples that had caused false positives results and also the supposedly defective product for investigational testing.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.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that two patient samples gave false positive results with the anti-d reagents of erytype s abd+rev.A1, b on tango infinity.The samples were rh negative when tested manually.The affected sample numbers are (b)(6) (the patient had a history of rhd negative) and (b)(6) (new patient).The customer stated that patient sample (b)(6) yielded a 2+ positive reaction and the other patient sample a 1+ positive reaction.Furthermore the customer stated the same two samples were tested again after the bromelin was freshly prepared.The rh(d) was negative this time for each sample.Additionally the customer reported another incidence of sample that was run on night shift that was rh positive using the tango infinity with the same lot of bromelin and some lot of plates.When run manually it was weak d negative.Repeated on tango infinity with fresh bromelin and it was rhd negative.The sample id is (b)(6).The customer provided two tango infinity images which looked very similar.The reaction strength was 1+ positive.The patients id was not on the images.Visually the reactions looked unusual in appearance.The customer also provided the complaint sample of erytype s abd+rev.A1, b for investigational testing and three samples labeled as (b)(6).Our quality control laboratory tested the patient samples (b)(6) with the complaint sample on tango infinity.Both samples yielded negative results.Sample (b)(6) could not be tested on tango infinity due the too low volume of the sample.Additionally the samples were sent to an external laboratory for molecular typing.The results were: sample (b)(6) : ccddee sample (b)(6) : ccd.Ee (interim result); dna-sequencing was not possible, because the amount and the quality of the isolated dna sample (b)(6) : ccd.Ee weak partial 15 (isbt: rhd*15).The complaint as well as our qc lab's retention sample of erytype s abd+rev.A1, b was tested with different samples and controls on tango infinity.All positive and negative reactions were correct.We did not observe any false positive reaction.The outcome of the investigation in the external laboratory was that only one of the provided patient samples was really rh(d) negative.This result explained the positive reactions on erytype at customer´s site.The section performance characteristics and limitations of the method of the instruction for use contains an appropriate note with regard to the reaction mode of weak d and d variant and erytype which occuured within the complaint handling of this particular case: "category dvii cells as well as very weak expressions of the d antigen (weak d or partial d with a very small number of receptors) may either react weakly or react negatively with both anti-d reagents." testing by our quality control laboratory confirmed the allegedly defective lot of erytype s abd+rev.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.The provided log files are incomplete; the most important file from the date of event is missing.An analysis is therefore not possible.The affected tango was inspected by one of our field service engineers.No indication for an instrument malfunction could be identified on current data.Log files were incomplete.The service engineer confirmed a proper function of the instrument.

• 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, 63303 ; GM 63303
• MDR Report Key: 9254224
• MDR Text Key: 219203384
• Report Number: 9610824-2019-00058
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Catalogue Number: 806127100
• Device Lot Number: 8847180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BROMELIN, # 8920150-00; BROMELIN, # 8920150-00; TANGO INFINITY, # 4230000139; TANGO INFINITY, # 4230000139