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

Catalog Number 07671687003

Device Problem Low Readings (2460)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is a lay user/patient.The meter and test strips were requested for investigation.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.There were 9 test strips of lot 507723-11 tested for the investigation.Testing results (qc range = 2.5 - 3.1 inr): qc 1: 2.8 inr.Qc 2: 2.8 inr.Qc 3: 2.8 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Product labeling states, "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." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation of discrepant inr results for one patient tested with a coaguchek xs meter serial number (b)(4) compared to a laboratory test with an unknown reagent.The result from the meter on (b)(6) 2021 between 8:00 am and 9:00 am was 3.3 inr.The result from the laboratory on (b)(6) 2021 at 11:34 am was 4.43 inr.The result from the meter on (b)(6) 2021 between 8:00 am and 9:00 am was 2.4 inr.The result from the laboratory on (b)(6) 2021 at 11:16 am was 3.39 inr.The patient¿s therapeutic range is 2.5- 3.5 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: 12453126
• MDR Text Key: 272781631
• Report Number: 1823260-2021-02653
• 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: 09/10/2021

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 Catalogue Number: 07671687003
• Device Lot Number: 50772311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/10/2021
• 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