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

Catalog Number 04625358003

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

One vial of test strip lot 46589116 was received for investigation.The test strips and vial showed no defects.The returned test strips were measured on reference meters with a high level control sample: control sample lot 455 699 00.Specified target range 2.7-3.3 inr (±11.5% around the lot specific target value of the complained test strip lot / control lot combination).Test 1: 3.1 inr, test 2: 3.1 inr, test 3: 3.0 inr.All inr values were within the specified target ranges, confirming the functionality of the complained coaguchek test strips.No error messages occurred.Routine retention testing was performed and passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." this event occurred in (b)(6).Unique identifier (udi) # (b)(4).Occupation was lay user/patient.

Event Description

There was an allegation of a questionable result from coaguchek xs meter serial number (b)(4).At 9:00, the laboratory result using an unknown reagent was 2.0 inr.At 10:00, the meter result was 2.6 inr.The therapeutic range was 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: 11425691
• MDR Text Key: 253268437
• Report Number: 1823260-2021-00690
• 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: 03/05/2021

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: 12/31/2021
• Device Catalogue Number: 04625358003
• Device Lot Number: 46589116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/05/2021
• 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
• Patient Age: 82 YR
• Patient Weight: 87