MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-I11

Catalog Number	816021100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a patient sample with an anti-d when tested with biotest cell-i11 in the manual test method.The customer stated that the anti-d yielded a correctly positive result with biotest cell-i11 on tango infinity.For the manual test method the customer had used biotest cell-i11 and the anti-human globulin from a competitor.The customer did neither return the supposedly defective product for investigational testing nor the patient sample that had caused a false negative test result.At the time we received the information that the false positive reaction occurred in the manual method and not on tango infinity, the supposedly defective product was expired.Therefore our quality control laboratory's retention sample was not tested manually.Within the shelf life of biotest cell-i11 our quality control laboratory tested their retention sample with different samples and controls, e.G.Anti-d from a proficiency testing on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell-i11 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I11
• Common Device Name: BIOTESTCELL-I11
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7721667
• Report Number: 9610824-2018-00047
• Device Sequence Number: 19237040
• Product Code: KSZ
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)180716(10)8821011-00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/26/2018

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: 07/16/2018
• Device Catalogue Number: 816021100
• Device Lot Number: 8821011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1