MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL BILIRUBIN SPECIAL; "DIAZO COLORIMETRY, BILIRUBIN"

Catalog Number 05795320190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2015

Event Type  malfunction  

Event Description

The customer reported erroneous results for one patient sample tested for bilirubin total gen.3 (bilt3).The initial bilt3 result was 1.26 mg/dl with a data flag.An automatic re-run was performed in decrease mode and the result was 0.52 mg/dl.The neat sample was repeated manually and the result was 1.35 mg/dl.The sample was repeated in manual decreased mode and the result was 0.41 mg/dl.The neat sample was repeated in a hitachi cup and the result was 1.06 mg/dl.The neat sample was manually diluted 1:2 with deionized water and the result was 0.70 mg/dl.The neat sample was repeated twice on (b)(6) 2015 and the results were 1.07 mg/dl with a data flag and 1.13 mg/dl with a data flag.The neat sample was repeated twice in decreased mode on (b)(6) 2015 and the results were 0.46 mg/dl and 0.45 mg/dl.The result of 1.35 mg/dl was reported outside of the laboratory.No adverse event occurred.The modular p800 module(evo) analyzer serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Further investigation determined that since control results were within range a reagent related issue could be excluded.The gammopathy patient sample results were correctly flagged three of five times processed with normal sample volume.The correct bilt3 patient result is assumed to be 0.47 mg/dl because of the reproducibility of the result in the diluted - not interfered- mode.The result 0.7 mg/dl obtained after a manual dilution 1:2 with deionized water could not be explained since data is missing.An additional turbidity in a higher amount compared to the results obtained in decreased mode is assumed to be the root cause.The result deviations from undiluted determinations vary because of the gammopathic nature of the patient sample.This is addressed in product labeling.Results from certain multiple myeloma patients may show a positive bias in recovery.Not all multiple myeloma patients show the bias and the severity of the bias may vary between patients.In very rare cases, gammopathy, in particular type igm (waldenström`s macroglobulinemia), may cause unreliable results.

• Brand Name: TOTAL BILIRUBIN SPECIAL
• Type of Device: "DIAZO COLORIMETRY, BILIRUBIN"
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4613660
• MDR Text Key: 5696913
• Report Number: 1823260-2015-02141
• Device Sequence Number: 1
• Product Code: CIG
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K063543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: 05795320190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1