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

Catalog Number 04625374160

Device Problem High Test Results (2457)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The patient's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.1 inr, qc 2: 3.1 inr, qc 3: 3.1 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 results alleged by the customer were observed in the meter¿s patient result memory.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." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) compared to a laboratory result using an unknown method.At 03:45 pm, the meter result was greater than 8.0 inr.The result was reported to patient¿s doctor and the doctor withheld the patient¿s coumadin for the night and told the patient to go hospital.The patient went to the emergency room and had blood drawn.At 06:00 pm, the laboratory result was 4.4 inr.The patient did not receive treatment based on her inr while at the hospital.The patient's therapeutic range is 2.0-3.0 inr.The patient¿s testing frequency is once every 1-2 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: 13119010
• MDR Text Key: 290451819
• Report Number: 1823260-2021-03942
• 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
• Report Date: 12/30/2021

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: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54145321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• 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: ACETAMINOPHEN CODEINE; AJOVY; ALLEGRA; AZELASTINE HCL; BALSALAZIDE SODIUM; BENZTROPINE MESYLATE; BUPROPION HCL ER; CLONIDINE HCL; CYCLOBENZAPRINE; DIVALPROEX SODIUM ER; FENOFIBRATE; FEXOFENADINE; FLONASE; GABAPENTIN; GLIMEPIRIDE; JANUVIA; LEXAPRO; METFORMIN; OMEPRAZOLE; PRAVASTATIN; RISPERIDONE; ROBAXIN; TIZANIDINE; VRAYLAR; WARFARIN
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 85 KG