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 08/27/2018

Event Type  malfunction  

Event Description

The customer received questionable high results from coaguchek xs meter serial number (b)(4) compared to the laboratory results.One example was provided.At 940 am, the result from the meter was 5.5 inr.At 940 am, the result from a laboratory using dade innovin reagent was 2.97 inr.There was no allegation of an adverse event.The patient was not anemic, had no heparin, no antiphospholipid antibodies, no direct thrombin inhibitor, no change to coumadin dose, no new medication, no diet change, no illness, and no symptoms of bleeding or bruising.The therapeutic range was 2.0-3.0 inr.The suspect meter and strips were requested to be returned for investigation.The meter was received and was tested with quality control material and retention test strips.Qc 1: 2.4 inr; qc 2: 2.4 inr; qc 3: 2.4 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(1.9 - 2.9 inr).All measurements were without error messages.Retention test strips (lot 304975) 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.The results alleged by the customer were not observed in the meter¿s patient result memory.No information was provided in the complaint case that would point to a cause for the result discrepancy.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: 7915241
• MDR Text Key: 122174262
• Report Number: 1823260-2018-03309
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04625315160
• Device Lot Number: 30497515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• 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
• Patient Age: 58 YR
• Patient Weight: 82