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

Catalog Number 04625374160

Device Problem Low Readings (2460)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).Occupation is lay user/patient.The patient's test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.1 - 3.3 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.The returned and the retention material meet the specification.The obtained results were in the allowed range.No error messages occurred during the investigation.Routine retention testing was performed.Test strip retention samples passed the internal inspection.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

There was a complaint of a discrepant inr result with coaguchek xs meter serial number (b)(4) when compared to a laboratory result using an unknown method.At 6:45 a.M.The meter result was 1.4 inr and at 8:30 a.M.The laboratory result was 2.0 inr.The patient's therapeutic range is 2.0-3.0 inr and tests every 2 weeks.

• 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: 11871844
• MDR Text Key: 252231548
• Report Number: 1823260-2021-01547
• Device Sequence Number: 1
• Product Code: GJS
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2021

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 50322621
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/24/2021
• 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
• Treatment: AMBIEN; KLONOPIN; LASIX; LOSARTAN; MULTIVITAMIN; TYLENOL AS NEEDED; VITAMIN D; WARFARIN
• Patient Age: 69 YR