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

Catalog Number 04625358003

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) (b)(4).Occupation is lay user/patient.This event occurred in (b)(6).The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Test strip retention samples passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin based laboratory method is compared to other laboratory methods." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.At 8:00 am, the result from the laboratory was 2.9 inr.At 8:30 am, the result from the meter was 2.1 inr.The customer has a therapeutic range of 2.3 inr.

• 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: 11657854
• MDR Text Key: 268511420
• Report Number: 1823260-2021-01134
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• 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