MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO INFINITY; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Catalog Number	850000010
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative reaction of one patient sample with both anti-d reagents of erytype s abd+rev.A1, b when tested on tango infinity.The customer stated that the issue occurred only once.In the repeat testing, the manual testing, and the testing on a second tango infinity available on-site, the results with both anti-d reagents were correctly positive.The customer did neither provide the complaint sample for investigational testing nor the patient sample that had caused the false negative test result.Therefore, our quality control laboratory is investigating their retention sample of the supposedly defective lot.The investigation is still ongoing.Regarding the affected tango infinity, the customer provided result images that show on (b)(6) 2021 the negative result for both rh clones and on repeat testing on (b)(6) 2021 strong 4+ positive results for both rh clones on both instruments.On the original image from (b)(6), all the forward testing wells (which are negative) are of the same color.But on repeat images (from both instruments) the anti-a well has a darker red color when compared to the ant-b well on the same strip.A field service engineer was on-site to check the affected instrument.He collected log files, performed a metrology check and ran a qc to verify the working order.No issues were found in mechanics, hydraulics, or operation of the instrument.The field service engineer found the instrument to be within manufacturer means and the tango infinity was returned to the customer for normal use.The log files did not show any issue relevant abnormalities.Loading of sample and pipetting were processed as expected.Sample barcode was scanned, no manual entry was found, and the loading position was the same as pipetting position.Due to the ongoing investigation, we are not in the position to provide a conclusive statement.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.From instrument's perspective, based on current information and data there is no indication for an instrument malfunction.
Event or Problem Description
The customer reported a false negative reaction of two patient samples with both anti-d reagents of erytype s abd+rev.A1, b when used on tango infinity.The customer stated that each of the two false negative results were a singular event and occurred only once.When retested manually and in one case on a second tango infinity at the customer's site, the results with both anti-d reagents were correctly positive.The customer did not provide the complaint sample of erytype s abd+reva1,b for investigational testing, but the two patient samples that had caused the false negative test results.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot of erytype abd+reva1,b.Different rh(d) positive and negative donor samples were tested on tango infinity and all positive and negative reactions were correct.We did not observe any false negative reaction.Furthermore, the patient samples were also tested with the retention sample of the supposedly defective lot and a reference lot on tango infinity.Both patient samples yielded clearly positive results on both erytype s abd+rev.A1, b plates.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected tango infinity, the customer provided result images for our investigation.The images show on (b)(6) 2021 the negative result for both rh clones and on retesting on (b)(6) 2021 strong 4+ positive results for both rh clones on both instruments.The customer also provided result images of a second case that showed on (b)(6) 2021 a negative result for both rh clones and on retesting on (b)(6) 2021 strong 4+ positive results for both rh clones on tango infinity (b)(6) the images of the second case were provided on (b)(6) 2021.The last preventive maintenance on the affected tango infinity was conducted on (b)(6) 2021.Analysis of the log files showed that the false negative anti-d detection is a caused by a wrong strip used for the sample processing, in the reported cases a solid screen ii strip instead of an abdrev a1b strip was processed.The usage of the wrong strip was caused by a hardware issue of a plate terminal component (plate mover).We analyzed all available log files for this device, this revealed some other occurrences, they are addressed in complaint (b)(4).A log file analysis of several other instruments did not reveal a comparable issue on any other device.Based on the results of this analysis, the customer was advised to stop using the device.A product support engineer was sent on site to check the whole plate terminal hardware module.He replaced the plate terminal on (b)(6) 2022 and this replacement solved the issue.The instrument is now ready to be released for routine use.Another identical case was reported on (b)(6) 2022 from this site for the same device, filed as (b)(4).This case was integrated into the ongoing investigations under quality notification number qn(b)(4) our initial report no.9610824-2021-00077 was issued for the erytype s abd+reva1,b plate.Since our investigation showed that the event was seemingly triggered not by the plate but by the instrument, this follow-up report is issued for the tango infinity.

• Brand Name: TANGO INFINITY
• Common Device Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 12859458
• Report Number: 9610824-2021-00077
• Device Sequence Number: 1778462
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)220515(10)8047060
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150327
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022
• 2 Devices were Involved in the Event: 1 2

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: 05/15/2022
• Device Catalogue Number: 850000010
• Device Lot Number: 8047060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERYTYPE S ABD+REV.A1, B, LOT 8047060; TANGO INFINITY, SN (B)(6)
• Patient Sex: Unknown