MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLSBIOTESTCELL 3

Catalog Number 816085100

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported a false negative result of a patient sample when tested with biotestcell 3 on tango infinity.The customer stated that the specificity of the known antibody is anti-d due to the rh(d) prophylaxis.The customer also stated that the reaction with cell #1 of biotestcell 3 is visually positive, but called negative by the instrument.The customer returned neither the supposedly defective product biotestcell 3 nor the patient sample that had caused a false negative test result.Testing 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 both allegedly defective lot.The affected tango infinity has been inspected by our field service engineers and found to be working within specifications.

Event Description

The customer reported a false negative result of a patient sample when tested with biotestcell 3 on tango infinity.The customer stated that the specificity of the known antibody is an acquired anti-d due to the rh(d) prophylaxis.He also stated that the reaction with cell #1 of biotestcell 3 was visually positive, but called negative by the instrument.The customer did not return a product sample for investigational testing but a patient sample labelled as #0811:bb3.The patient sample the customer provided was not the one with the missed acquired anti-d, but a patient sample with an anti-e.The customer stated that this patient sample yielded a 1+ positive reaction on one tango infinity and a negative (but visually weak positive) reaction on the other tango infinity.At the time we received the patient sample the affected lot of biotestcell 3 was already expired.Therefore the patient sample was tested with the current sample of biotestcell #3 (lot #8831011-00) and yielded a negative result.Additionally the sample was tested with biotestcell-i11.Due to the lack of sample material the results of tango infinity could not be assessed.Additional tests were not possible, because the sample was used up.Within its shelf life the supposedly defective product was tested with different samples and controls.All reactions were as expected.We did not observe any false negative reaction.Due to our test results there is no evidence of a confirmed malfunction of the supposedly defective lot.The instruction for use contains a note in the section limitation: "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." 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 infinity has been inspected by our field service engineers and found to be working within specifications.

Manufacturer Narrative

This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLSBIOTESTCELL 3
• Type of Device: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7808414
• MDR Text Key: 118403758
• Report Number: 9610824-2018-00050
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)180827(10)8827021-00
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2018
• Device Catalogue Number: 816085100
• Device Lot Number: 8827021-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTESTCELL I11 PLUS, LOT 8827011-00; BIOTESTCELL I11 PLUS, LOT 8827011-00; TANGO INFINITY, # 4230000157; TANGO INFINITY, # 4230000157