MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND SOLIDSCREEN II; SOLIDSCREEN II ANTI-D BLEND, 5ML

Catalog Number	806530100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a rhd discrepancy of one donor sample with solidscreen ii anti-d blend when used on tango optimo.The customer stated that the donor is known to be blood group o rhd negative but yielded a positive result with solidscreen ii anti-d blend on tango optimo.The customer did not return the supposedly defective product for investigational testing but the donor sample that caused the false positive reaction with solidscreen ii anti-d blend on tango optimo.Testing of the donor sample 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.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a rhd discrepancy of one donor sample when tested with solidscreen ii anti-d blend on tango optimo.The customer stated that the donor was known to be blood group o rhd negative but yielded a positive result with solidscreen ii anti-d blend on tango optimo.The customer stated that the donor unit sample was retested on the tango optimo and the result was positive again.The sample was also tested manually and resulted as rhd negative.The customer did not return the supposedly defective product solidscreen ii anti-d blend for investigational testing but the donor sample (labeled as (b)(6) ) that had caused the false positive reaction with solidscreen ii anti-d blend on tango optimo.Therefore our quality control laboratory tested the donor unit sample with their retention sample of solidscreen ii anti-d blend on tango optimo and could confirm the customer´s finding.Additionally our quality control laboratory tested the donor unit sample on erytype s abd+rev.A1, b and yielded negative results with both anti-d reagents.Furthermore the donor unit sample was tested manually with seraclone anti-d blend: the immediate spin method as well as the indirect antiglobulin test (iat) yielded a negative result.Furthermore the retention sample was tested with two different controls.All positive and negative reactions were correct.The donor unit sample was sent for molecular rhd determination to an external laboratory.The result of the external laboratory was: ccddee.Based on the serological investigation with solidscreen ii anti-d blend the complaint was classified as confirmed.The cause of the false positive result remains unknown.Because the donor sample was used up we requested an additional donor sample to investigate the cause of the false positive reaction.We were informed that no donor sample is available for further investigation.Therefore the root cause of the false positive result remains unknown.Testing by our quality control laboratory confirmed the correct function of the allegedly defective lot of solidscreen ii anti-d blend.Only one single donor sample with the rh phenotype ccddee showed a positive reaction with solidscreen ii anti-d blend.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.We did not receive any further complaints related to this issue.Regarding the affected tano optimo: log files and result images were not made available for evaluation.The instrument was inspected by our field service engineer and according to the service report the instrument had no problems after performance testing.No indication for an instrument malfunction could be identified.The instrument gave repeatedly the same results and the issue is likely not linked to instruments performance.The instrument was confirmed to operate within specification by our field service engineer.

• Brand Name: BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND SOLIDSCREEN II
• Common Device Name: SOLIDSCREEN II ANTI-D BLEND, 5ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 8924316
• Report Number: 9610824-2019-00047
• Device Sequence Number: 19485278
• Product Code: KSZ
• UDI-Device Identifier: 07611969951512
• UDI-Public: (01)07611969951512(17)201126(10)8848040
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 11/26/2020
• Device Catalogue Number: 806530100
• Device Lot Number: 8848040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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: ERYTYPE S ABO CONFIRM, LOT 8841150; ERYTYPE S ABO CONFIRM, LOT 8841150; TANGO OPTIMO, # 9142400566; TANGO OPTIMO, # 9142400566