MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 cobas c 502 module is 17g4-03.The investigation reviewed the last calibration performed on 27-oct-2023; no issues were noted.The investigation reviewed the qc data from 01-oct-2023 to 03-nov-2023; the recoveries for both levels were within the +/- 2 standard deviation (sd ) range.The investigation reviewed the alarm trace provided; there were several "abnormal aspiration", "sample clot detected" and "sample short" alarms present in the trace.The investigation reviewed the reaction monitor of the initial run and rerun; the reaction monitor of the initial run seemed to show that not enough sample was pipetted; the reaction monitor of the rerun is inconspicuous.The customer stated that they had placed a false bottom tube on a normal rack and not on a rack that was defined for false bottom tubes.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable bilt3 bilirubin total gen.3 result from one patient sample tested on the cobas 8000 cobas c 502 module.The patient sample was rerun because the result from the patient's previous sample was 156 umol/l.The initial result was 10.8 umol/l.The repeat result was 209.8 umol/l.
Additional Manufacturer Narrative
The investigation reviewed the customer's handling of patient samples.It was noted that the tube manufacturer's recommended centrifugation speed was 6000-15000g, but the speed on the preanalytical checklist is 3840.The investigation ruled out a general reagent issue because the calibration and qc results were acceptable.The investigation determined the event was consistent with a preanalytic issue at the customer site (reaction monitor of initial run looks like not enough sample was pipetted; sample short.Sample clot and abnormal aspiration alarms in the alarm trace; incorrect centrifugation speed; false bottom tube was placed on a rack not defined for false bottom tubes).Preanalytics are within the customer's responsibility.Product labeling states "false bottom tubes the instrument recognizes false bottom tubes by the rack id.¿ the rack must be assigned on the false bottom 1 tab of utility > system > rack assignment.¿the instrument handles all containers on this rack as false bottom tubes, regardless of their height." there was no indication of a device malfunction.

• Brand Name: BILT3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18210069
• Report Number: 1823260-2023-03763
• Device Sequence Number: 7373120
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: K131544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 09/30/2024
• Device Catalogue Number: 05795397190
• Device Lot Number: 68886401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown