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

Catalog Number	ASKU
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received an erroneous result for one patient sample tested for vanc3 vancomycin on a cobas 6000 c (501) module - c501.The patient did not have any known gammopathy.The sample initially resulted with a vanc3 value of 124.1 ug/ml accompanied by a data flag.The sample was diluted 1:3 and repeated, resulting with a raw value of 32.6 ug/ml which calculated to a final value of 97.8 ug/ml when accounting for the dilution factor.The sample was also diluted 1:3 and repeated a second time, resulting with a raw value of 30.9 ug/ml which calculated to a final value of 92.7 ug/ml when accounting for the dilution factor.The 92.7 ug/ml value was reported outside of the laboratory.The biologist was surprised by the high value as the patient's vancomycin medication (2500 mg.) was stopped on (b)(6) 2018.He asked for the sample to be repeated at a second laboratory.The sample was repeated at the second laboratory on a siemens dimension analyzer on (b)(6) 2018, resulting as 0.9 mg/l.No adverse events were alleged to have occurred with the patient.The c501 analyzer serial number was (b)(6).All levels of quality controls were within range for the month of july.Calibration signals for the last calibration performed on (b)(6) 2018 were consistent.A general issue with the reagent and instrument could be excluded as calibration and quality controls were acceptable.
Additional Manufacturer Narrative
No device problem found.The root cause of the event could not be determined.

• Brand Name: VANCOMYCIN
• Common Device Name: RADIOIMMUNOASSAY, VANCOMYCIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7762047
• Report Number: 1823260-2018-02641
• Device Sequence Number: 19162338
• Product Code: LEH
• UDI-Device Identifier: 04015630934416
• UDI-Public: 04015630934416
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 290451
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 12/01/2018
• 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: REFER TO THE ATTACHMENT FOR PATIENT MEDICATION
• Patient Age: 72 YR