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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned without a lid on the storage container and was exposed to moisture.

Event Description

The customer complained of discrepant inr results for 1 patient from coaguchek xs meter serial number (b)(4) compared to the laboratory.At 1:30 pm, the results from the meter were 5.1 inr, 5.8 inr, 4.9 inr.The customer was not sure if a different finger was used.The result from the laboratory was 3.7 inr.The exact time was not provided.The exact time of the lab result was not provided but was stated as within a few minutes later.There was no allegation of an adverse event.The patient was "stable".The patient was not anemic or polycythemia, no heparin, lovenox, no antiphospholipid antibodies, and no direct thrombin inhibitors.The patient has had no changes in coumadin, no changes in diet, no illness, no changes in medications, no bleeding, and no bruising.The patient had started a new medication for depression.The patient's therapeutic range was 2.0 - 3.0 inr.Retention test strips were measured on the returned meter with liquid qc of a high level in comparison to masterlot #28632180 on an internal reference meter.Qc 1: 2.6 inr; qc 2: 2.6 inr; qc 3: 2.6 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(2.0-3.0 inr).No error messages occurred during the investigation.Retention test strips (lot 286322) were tested in comparison to masterlot #28632180.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 specification.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
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7918617
• MDR Text Key: 122046685
• Report Number: 1823260-2018-03342
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04625315160
• Device Lot Number: 28632213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 09/28/2018
• 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
• Type of Device Usage: N
• Removal/Correction Number: 1823260-08/30/18-005-C
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CARVEDILOL; COUMADIN (WARFARIN SODIUM); FAMOTIDINE; FUROSEMIDE; KLOR-CON; SERTARLINE; VITAMIN D3
• Patient Age: 56 YR
• Patient Weight: 120