MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC; ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML

Catalog Number	804115100
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative results of two api proficiency samples labeled as dat-05 and dat-06 with anti-human globulin (ahg) anti-igg, -c3d; polyspecific in the tube method.According to the report from api, one sample should be positive due to complement load and one because of both complement and igg load.The customer so far was not able to provide a date of event.The customer announced to send in a product sample for investigational testing, our quality control laboratory is still waiting for the sample.Meanwhile our quality control laboratory tested their retention sample of the supposedly defective lot of anti-human globulin anti-igg, -c3d, polyspecific for potency and specificity.During this testing the anti-igg part as well as the anti-complement part of the ahg were tested.All acceptance criteria were met.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have had a negative impact 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 false negative results of two proficiency samples (dat-05 and dat-06) with anti-human globulin (ahg) anti-igg, -c3d; polyspecific (ref #804115100, lot #8749190-03) in the tube method.Both samples should have been positive with ahg polyspecific, one due to the complement and one due to both complement and igg.Furthermore the customer stated that she re-tested the proficiency samples with anti-human globulin (ahg) anti-igg, -c3d; polyspecific (ref #804115100, lot #8921280-03) and also received negative results.The date of event remains unknown.The customer did return neither he proficiency samples dat-05 and dat-06 that had caused false negative test results nor the supposedly defective products for investigational testing.Therefore our quality control laboratory tested their retention samples of the supposedly defective lots #8749190-03 and #8921280-03 for potency and specificity.Within the potency testing the anti-igg amount as well as the anti-complement part were tested.All positive and negative reactions were correct and the acceptance criteria were met.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC
• Common Device Name: ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9754747
• Report Number: 9610824-2020-00007
• Device Sequence Number: 3608555
• Product Code: QHS
• UDI-Device Identifier: 07611969950652
• UDI-Public: (01)07611969950652(17)200224(10)8749190-03
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 125242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 01/05/2021

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: 02/24/2020
• Device Catalogue Number: 804115100
• Device Lot Number: 8749190-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1