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

Catalog Number	804175100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
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 direct antiglobulin test (dat) of a cap survey sample when tested in the manual tube method with anti-igg.The customer did not return the supposedly defective product for investigational testing, but the cap survey sample that had caused a false negative test result.Our quality control laboratory tested the cap survey sample with their retention sample of anti-igg and a reference lot that the customer had used in a retest.Our quality control laboratory performed the direct antiglobulin test (dat) and yielded a correctly positive result with both anti-igg.Additionally the retention sample and the reference lot were tested for positive and negative specificity and potency.All acceptance criteria were met for both anti-igg reagents.We did not observe any false negative result.Testing by our quality control laboratory confirmed that the allegedly defective lot of anti-igg 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: ANTI-HUMAN GLOBULIN ANTI-IGG
• Common Device Name: ANTI-HUMAN GLOBULIN, ANTI-IGG; 10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7825686
• Report Number: 9610824-2018-00053
• Device Sequence Number: 16755844
• Product Code: KSZ
• UDI-Device Identifier: 07611969950652
• UDI-Public: (01)07611969950652(17)200529(10)8724090-02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/29/2018

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: 05/29/2020
• Device Catalogue Number: 804175100
• Device Lot Number: 8724090-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1