MAUDE Adverse Event Report: ROCHE DIAGNOSTICS VANCOMYCIN; RADIOIMMUNOASSAY, VANCOMYCIN

Model Number	VANCOMYCIN G3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer replaced the reagent cassette with a new one (lot 574735) due to qc being out.The customer states they have not experienced any further issues since.The last calibration was performed on (b)(6) 2022 met acceptance criteria with no alarms.The investigation noted the signals for the affected cassette were much lower when compared to the previous calibration history.The qc met acceptance criteria prior to the event.The qc was out of range for all levels when the customer reran the qc after the event occurred.The customer declined a field service engineer (fse) visit as they resolved the issue by replacing the affected reagent with a new cassette.
Event or Problem Description
There was a complaint of questionable vancomycin results for 4 patients tested with cobas 6000 c501 module serial number (b)(4).The questionable results were reported outside the laboratory.The pharmacist questioned the results which prompted a repeat.The patients¿ samples were repeated for a second time on a different c501 module.Patient 1¿s initial result was < 4.0 ug/ml accompanied by a data flag; the first repeat result was 4.2 ug/ml, the second repeat was 11.1 ug/ml.Patient 2¿s initial and first repeat results were < 4.0 ug/ml accompanied by a data flag; the second repeat was 20.3 ug/ml.Patient 3¿s initial result was < 4.0 ug/ml accompanied by a data flag; the first repeat result had no numerical value but was flagged by a data flag, the second repeat was 19.7 ug/ml.Patient 4¿s initial and first repeat results were < 4.0 ug/ml accompanied by a data flag; the second repeat was 14.6 ug/ml.The customer believes the second repeated result to be correct.

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13516053
• Report Number: 1823260-2022-00351
• Device Sequence Number: 5311888
• Product Code: LEH
• UDI-Device Identifier: 04015630934447
• UDI-Public: 04015630934447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060586
• 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
• Report Date (Section B): 02/11/2022

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: 11/30/2022
• Device Model Number: VANCOMYCIN G3
• Device Catalogue Number: 06779344190
• Device Lot Number: 55134601
• 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: 01/18/2022
• Initial Report FDA Received Date: 02/11/2022
• 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