MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL); ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML

Catalog Number	804115100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that he got false negative test results when performing tube testings with known samples by using the product ahg anti-igg,-c3d , lot # 8630053-01 for testing, a crossmatch of a (b)(6) survey showed a false negative test result.Furthermore a confirmed anti d positive sample showed negative test results when using the complained product ahg with the product seraclone anti-d in tube testing.The customer returned the supposedly defective product ( ahg anti-igg,-c3d , lot # 8630053-01), three cap samples and the blood sample that had caused false negative results for investigational testings.The quality control laboratory investigation is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that he got false negative test results when performing tube testings with known samples by using the product ahg anti-igg,-c3d , lot # 8630053-01 for testing, manual tube testing performing a crossmatch with j-9 and j-13 (cap survey).The crossmatch was compatible and gave a negative reaction.The customer failed the cap survey by reporting a negative result but it was positive.Repeating the crossmatch the reaction (under the microscope) was weakly positive.The customer performed a unit confirmation on an a pos.Sample.The result was rh(d) negative but it should have been positive.The customer returned the ahg, anti-igg,-c3d, the cap survey samples j-09r, j-09s and j-13r as well as a blood sample (segment) that caused false negative test results for investigational testing.The complained ahg sample returned by the customer was tested by titration in parallel to our quality control laboratory's retained sample and a reference lot.All results were as expected.Then crossmatch was performed with compatible and incompatible crossmatch testing.We also tested the cap survey samples j-13r and j-09s that were provided by the customer, and the result was clearly positive.Donor j-13r has got an antigene jk b.Sample j-09s was tested to have an anti-jkb.This is why the reaction of the crossmatch has to be positive (iat).We obtained a positive reaction with all tested ahg`s (the complaint bottle, the retained ahg and the reference lot).We did not yield any false negative result.The blood sample provided by the customer was also tested with seraclone anti-d (bs226) #8603070-01 and initially yielded a negative reaction (igm).Afterwards a test for weak d characteristics (d weak or d variant) was performed with seraclone anti-d (rh1) blend, #8650070-05 (igg/igm).This test has to be done in an indirect antiglobulin test.The reactions were all 4+ positive with the ahg from the customer as well as with the retained ahg.That result is a clear indication for weak d characteristic of the patient sample.Testing in our quality control laboratory confirmed that the allegedly defective lot of ahg, anti-igg,-c3d; polyspecific functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The reagent worked as expected and the patient sample was clearly identified to have a weak d.

• Brand Name: ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)
• Common Device Name: ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6864093
• Report Number: 9610824-2017-00067
• Device Sequence Number: 19012205
• Product Code: KSZ
• UDI-Device Identifier: 07611969950652
• UDI-Public: 07611969950652
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 10/10/2018
• Device Catalogue Number: 804115100
• Device Lot Number: 8630050-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1