MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D BLEND; SERACLONE ANTI-D BLEND

Catalog Number	802033100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false negative result of a donor sample when tested with seraclone anti-d blend.The customer stated that he typed the donor sample as blood group o rh(d) negative but it was supposed to be blood group o rh(d) positive.The exact date of event is unknown but the customer believes it to have happened at the beginning of (b)(6) 2018.The customer returned neither the supposedly defective product nor the donor sample that had caused a supposedly false negative result.Therefore our quality control laboratory tested their retention sample of seraclone anti-d blend for potency and specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.The minimum titer was met.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-d blend 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: BLOOD GROUPING REAGENT ANTI-D BLEND
• Common Device Name: SERACLONE ANTI-D BLEND
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8291666
• Report Number: 9610824-2019-00001
• Device Sequence Number: 10778032
• Product Code: KSZ
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)191008(10)8742060-03
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2019
• Device Catalogue Number: 802033100
• Device Lot Number: 8742060-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1