MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number	07797826160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of discrepant inr results for 2 patients from coaguchek plus meter serial number (b)(4).For patient 1 the results from the meter were 7.2 inr, 4.8 inr, and 4.2 inr with the same finger.For patient 2 the results from the meter were 3.4 inr, 2.6 inr, and 3.3 inr with the same finger.Patient 2 was a (b)(6) female with a date of birth of (b)(6).The specific time of the measurements was not provided.The elapsed time between the measurements was within 15 minutes for both patients.There was no allegation of an adverse event.The patients' warfarin doses were adjusted based on the results from the meter.The patients were feeling "okay".The patients were not anemic, no heparin, no antiphospholipid antibodies, and no direct thrombin inhibitors.The patients had no changes in diet, no new illness, no new medications, no bleeding, and no bruising.The patients' therapeutic ranges were 2.0 - 3.0 inr.Retention test strips (lot 294947) were tested in comparison to master lot.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material complies with the specification.The returned test strips were measured at the returned meter with liquid qc of a high level in comparison to masterlot on internal reference meter: qc: 2.4 inr; qc: 2.3 inr; qc: 2.3 inr.The obtained qc results were in the allowed range.No error messages occurred during the investigation.Extensive measurements have shown higher deviations for coaguchek values > 4.5 inr compared to a laboratory method.Therefore, the customer allegation has been substantiated.A product problem has been found for coaguchek values > 4.5 inr, which was the case in this complaint.This can be traced back to the calibration of the complained test strips to the who standard rtf/16.For measurements > 4.5 inr.The customer is advised to contact the physician and perform a measurement with a laboratory method.Roche diagnostics has issued a recall for this issue.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7905453
• Report Number: 1823260-2018-03279
• Device Sequence Number: 1692994
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• 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
• Report Date (Section B): 09/25/2018

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: 09/30/2019
• Device Catalogue Number: 07797826160
• Device Lot Number: 29494711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1823260-08/30/18-005-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1: WARFARIN; PATIENT 2: ATRIPTALINE; PATIENT 2: CYMBALTA; PATIENT 2: FLONASE; PATIENT 2: LOSARTAN; PATIENT 2: PRILOSEC; PATIENT 2: REQUIP; PATIENT 2: SINGULAIR VITAMIN; PATIENT 2: WARFARIN; PATIENT 2: WELLBUTRIN
• Patient Age: 70 YR