MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	03183734190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable tp2 total protein gen.2 results for one patient sample from cobas 6000 c 501 module serial number (b)(4).The initial result was 9.0 g/dl and was reported outside of the laboratory.The repeat result with a 1:10 dilution was 9.8 g/dl.The result by shikoku chuken method was 7.7 g/dl.There was no allegation of an adverse event.As calibration and qc data were acceptable, a general reagent or application could be ruled out.
Additional Manufacturer Narrative
The investigation did not identify a product problem.  the cause of the event could not be determined. .

• Brand Name: TOTAL PROTEIN GEN.2
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7800497
• Report Number: 1823260-2018-02785
• Device Sequence Number: 19216358
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 09/14/2018

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: 07/31/2019
• Device Catalogue Number: 03183734190
• Device Lot Number: 335972
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1