MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL POOL; BIOTESTCELL POOL, 10 ML

Catalog Number	816065100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported tht an anti-k was supposedly missed when testing a patient sample with biotestcell pool on tango optimo.Investigation in our quality control laboratory is still ongoing.An internal quality notification for exceeding the reporting deadline to fda has been raised.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a patient sample when tested with biotestcell pool on tango optimo.The patient had a known anti-k.The customer stated that the antibody was detected in the tube and the gel method.The reaction strength was 1 to 2+ positive.In our initial report, the date of event was erroneously stated as (b)(6) 2019 when it should have been (b)(6) 2019.The customer returned the patient sample that had caused a false negative test result for investigational testing and also the supposedly defective product biotestcell pool.At the time we received the supposedly defective product it was already expired.Therefore our quality control laboratory tested the patient sample with the current lot of biotestcell pool on tango optimo.The patient sample yielded a weak positive reaction.Within its shelf life, our qc lab tested the retention sample of the supposedly defective biotestcell pool lot with different samples and controls on tango optimo, e.G.An anti-k.All positive and negative reactions were correct.We did not observe any false negative reactions.Additionally the patient sample was tested in the gel technique and yielded a weak positive reaction.All test results suggest that the anti-k of the patient sample is a weak reacting antibody.The instruction for use contains a corresponding 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 the correct function of the allegedly defective lot of biotestcell pool.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Regarding the affected tango optimo: result images provided by the customer were reviewed.A field service engineer performed metrology per procedure on the tango optimo and also post service verification as required.The instrument was found to be operating within manufactures specifications and is returned to service.A metrology qualification was performed as per checklist with passing qc results.The post adjustment camera setting values were within acceptable range.The log files did not show any issue relevant abnormalities.No identification for an instrumet malfunction could be identified.The service engineer confirmed a proper function of the instrument by metrology certificate.
Additional Manufacturer Narrative
This report is sent because our initial and our final report provided an incorrect product code.
Event or Problem Description
The customer reported a false negative reaction of a patient sample when tested with biotestcell pool on tango optimo.The patient had a known anti-k.The customer stated that the antibody was detected in the tube and the gel method.The reaction strength was 1 to 2+ positive.In our initial report, the date of event was erroneously stated as (b)(6) 2019 when it should have been (b)(6) 2019.The customer returned the patient sample that had caused a false negative test result for investigational testing and also the supposedly defective product biotestcell pool.At the time we received the supposedly defective product it was already expired.Therefore our quality control laboratory tested the patient sample with the current lot of biotestcell pool on tango optimo.The patient sample yielded a weak positive reaction.Within its shelf life, our qc lab tested the retention sample of the supposedly defective biotestcell pool lot with different samples and controls on tango optimo, e.G.An anti-k.All positive and negative reactions were correct.We did not observe any false negative reactions.Additionally the patient sample was tested in the gel technique and yielded a weak positive reaction.All test results suggest that the anti-k of the patient sample is a weak reacting antibody.The instruction for use contains a corresponding 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 the correct function of the allegedly defective lot of biotestcell pool.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Regarding the affected tango optimo: result images provided by the customer were reviewed.A field service engineer performed metrology per procedure on the tango optimo and also post service verification as required.The instrument was found to be operating within manufactures specifications and is returned to service.A metrology qualification was performed as per checklist with passing qc results.The post adjustment camera setting values were within acceptable range.The log files did not show any issue relevant abnormalities.No identification for an instrumet malfunction could be identified.The service engineer confirmed a proper function of the instrument by metrology certificate.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL POOL
• Common Device Name: BIOTESTCELL POOL, 10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 9552690
• Report Number: 9610824-2019-00081
• Device Sequence Number: 11681657
• Product Code: QHT
• UDI-Device Identifier: 07611969952670
• UDI-Public: (01)07611969952670(17)191219(10)8943011-00
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 04/21/2020

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: 12/16/2019
• Device Catalogue Number: 816065100
• Device Lot Number: 8943011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 12/02/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/03/2020; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO OPTIMO, SN (B)(6) ; TANGO OPTIMO, SN (B)(6) ; TANGO OPTIMO, SN (B)(6)