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

Catalog Number	06779336190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that they had questionable results for an unspecified number of patient samples tested for vanc2 vancomycin on a cobas 6000 c (501) module.The customer provided data for one patient sample which had an erroneous vanc2 result that was reported outside of the laboratory.A first sample was collected from the patient and this resulted with a vanc2 value of 0.0 ug/ml.The customer re-centrifuged this first sample and repeated it, resulting with a vanc2 value of 0.0 ug/ml.The customer then requested a second sample to be collected from the patient.The second sample initially resulted with a vanc2 value of 0.0 ug/ml.This sample was then re-centrifuged and repeated, resulting with a vanc2 value of 0.0 ug/ml.The customer reported a value of less than 1.7 ug/ml outside of the laboratory to the floor.This second sample was repeated on (b)(6) 2018, resulting with a value of 17.9 ug/ml.The value of 17.9 ug/ml was believed to be correct and this value fit the clinical picture of the patient.No adverse events were alleged to have occurred with the patient.The c 501 analyzer serial number is (b)(4).The field service engineer determined that the issue was related to the reagent pack that was used.The customer changed the reagent pack.The customer calibrated the new pack, and then ran controls.The customer had no further issues after doing this.The engineer checked the analyzer and adjusted the rinse water level in the cuvettes.The customer performed maintenance on the analyzer, including replacing the cells and lamp.The engineer verified operation of the analyzer and ran precision studies.The customer ran controls and verified these results.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The 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: 7872103
• Report Number: 1823260-2018-03114
• Device Sequence Number: 16629109
• Product Code: LEH
• UDI-Device Identifier: 04015630934416
• UDI-Public: 4015630934416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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 Expiration Date: 05/31/2019
• Device Catalogue Number: 06779336190
• Device Lot Number: 29045101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2018
• Supplement Date Received by Manufacturer: 08/26/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: ABILIFY; CLONZEPAM; FOLIC ACID; HEPARIN; LACALOSE; LIDICAIN; LIPITOR; MAGNESIUM; MERALAX; PROTONIX; SULFATE; TRAMADOL; TYLENOL; VANCOMYCIN; ZOFRAN; ZOLOF; ZOSYN; ABILIFY; CLONZEPAM; FOLIC ACID; HEPARIN; LACALOSE; LIDICAIN; LIPITOR; MAGNESIUM; MERALAX; PROTONIX; SULFATE; TRAMADOL; TYLENOL; VANCOMYCIN; ZOFRAN; ZOLOF; ZOSYN
• Patient Age: 73 YR
• Patient Weight: 77