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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 03/31/2022

Event Type  Injury  

Event Description

We received an allegation of a questionable inr result from a coaguchek xs meter with serial number (b)(4) that allegedly caused a patient to be hospitalized due to bleeding.The patient's blood pressure was reportedly low.The meter result at an unknown time was reported to be 3.7 inr.The result was reported to the doctor, who reportedly advised the patient to go to the emergency room immediately.While at the hospital, blood was reportedly found in the patient's stool.The laboratory result at 6:12 pm from a venous draw was reported to be 7.4 inr.The patient was reportedly given vitamin k to bring the inr down.The patient was also reportedly given a blood transfusion.The therapeutic range was reported to be 2.5 inr to 3 inr.The interval of testing was reported to be once a week.

Manufacturer Narrative

The test strips and meter were requested for return.The test strips used on the date of the event were no longer available.The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr; qc 2: 2.9 inr; qc 3: 2.9 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 not observed in the meter¿s patient result memory because the results were erased prior to the delivery to the investigation site.Per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." the investigation did not identify a product problem.The cause of the event could not be determined.Occupation is patient/consumer.

• 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: 14367251
• MDR Text Key: 291481406
• Report Number: 1823260-2022-01368
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 05/12/2022
• 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: BABY ASPIRIN; FAMOTIDINE; FENOFIBRATE MICRONIZED; MUCINEX; SUCRALFATE 1G X4 DAILY; TYLENOL AS NEEDED; VITAMIN C 500 MG; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 60 KG