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

Catalog Number 04625374160

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

There was a complaint of questionable inr results with coaguchek xs meter (b)(4) compared to an unknown laboratory method.The result from the meter memory at 10:22 a.M.Was 2.7 inr.The patient¿s wife was adamant the result from the meter was 1.2 inr, which was written in the logbook and reported.The result from the laboratory within four hours was 2.5 inr.The patient¿s therapeutic range is 2.5-3.5 inr.

Manufacturer Narrative

Initial reporter's occupation: occupation is patient/consumer(patient¿s wife).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.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.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.".

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 3.0 inr.Qc 2: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's alleged result of 1.2 inr meter result on (b)(6) 2021 was not observed.All other alleged results were observed in the meter's patient result memory.A full display check was performed and revealed no missing or faded segments.No display issues were observed.Review of the meter memory observed error 8 on (b)(6) 2021 at 10:20 am, just 2 minutes prior to the customer receiving a result of 2.7 inr.Error 8 occurs when the target temperature is not reached by the heater because the power level of the batteries are too low.Medwatch fields d9 and h3 have been updated.

• 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: 13118181
• MDR Text Key: 285225434
• Report Number: 1823260-2021-03935
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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,Followup
• Report Date: 03/14/2022

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: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49408221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/14/2022
• 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: ABIRATERONE; FUROSEMIDE; IRON INJECTIONS; PREDNISONE; SIMVASTATIN; TAMSULOSIN; VITAMIN C; WARFARIN
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 59 KG