MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BIOTESTCELL 3

Catalog Number 816085100

Device Problems False Negative Result (1225); Defective Device (2588)

Patient Problems Autoimmune Reaction (1733); Missed Dose (2561)

Event Date 04/24/2014

Event Type  Injury  

Event Description

The customer reported that he missed an antibody when testing with biotestcell 3 on tango optimo.The antibody not detected caused a hemolytic transfusion reaction.The customer has returned the patient sample that had caused the false negative result, but not the supposedly defective product.Testing of the retained biotestcell 3 sample in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo went through scheduled preventive maintenance on (b)(6) 2014 with no issues.The very same tango optimo was most thoroughly inspected by two field service engineers on (b)(6) 2014 with not the slightest indication for any performance issues.Four sample were tested in a serial dilution of up to 1:32 on instrument in question with no sensitivity issues.There is no indication for a malfunction of the affected tango optimo.

Manufacturer Narrative

This is our initial report on this incident.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that he missed an antibody when testing with biotestcell 3 on tango optimo.The antibody not detected caused a hemolytic transfusion reaction.The customer reported that in the sample drawn before transfusion an anti-c could be identified.In a patient sample drawn after the transfusion additionally an anti-jk(b) could be identified.The customer did return two patient samples ((b)(6)) that were drawn after the transfusion, but not the supposedly defective product biotestcell 3.The red blood cells had been separated from the plasma.The customer did not return the patient sample that had caused a false negative test result.Upon receipt of the patient samples, the supposedly defective product biotestcell 3 was already expired.In spite of this fact the patient samples were tested with the expired lot of biotestcell 3 and the current lot of biotestcell 3.Both samples were tested on tango optimo with our quality control laboratory's retained biotestcell 3 lot 8412011-00 sample, the allegedly defective lot that had already expired.Only reagent red blood cell #1 (c pos., jka-b+) yielded positive results.(b)(4)).The samples were also tested with biotestcell 3 lot 8420011-00.Reagent red blood cell #1 (c pos.Jkb neg.) reacted with both samples clearly positive (3w, 3+).Sample 052014 also showed a +/- reaction with red blood cell #2 (jka- b+).Additional identification testing did not yield an antibody result.Sample id (b)(4) reacted only with i3 (c pos., jka+b-) and i11 (c pos., jka-b+) of biotescell i11.Sample id (b)(4) with i1(c pos., jka+b-) and i3 (c pos., jka+b-).The reaction strengths were +/- till 1+.Further testing in gel (liss/coombs) with biotestcell 3 and id-diacell i-ii-iii yielded with the corresponding red blood cells negative till 2w reactions.Only in tube with the enhancement polyethylene glycol (peg) the provided patient samples reacted with the corresponding reagent red blood cells correctly positive with all cells having the corresponding antigen.The test results strongly suggest that both antibodies are weak reacting antibodies, especially the anti-jk(b).The instruction for use contain an appropriate hint: negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method employed.No test method is capable of detecting all red cell antibodies.The supposedly defective product biotestcell 3 was tested with different known antibodies, amongst others anti-c and anti-jkb.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 biotestcell 3 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 affected tango optimo went through scheduled preventive maintenance on april 23, 2014 with no issues.The very same tango optimo was most thoroughly inspected by two field service engineers on may 12, 2014 with not the slightest indication for any performance issues.Four sample were tested in a serial dilution of up to 1:32 on instrument in question with no sensitivity issues.There is no indication for a malfunction of the affected tango optimo.

• Brand Name: BIOTESTCELL 3
• Type of Device: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 6330 3; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 1033130 57
• MDR Report Key: 3842423
• MDR Text Key: 4662796
• Report Number: 9610824-2014-00044
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2014
• Device Catalogue Number: 816085100
• Device Lot Number: 8412011-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AHG, LOT 8343150-02, EXP. 2015-04-18; TANGO OPTIMO, # (B)(4); MLB2, LOT 8334090-00; SOLIDSCREEN II STRIP, LOT 8324050
• Patient Outcome(s): Other