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

Catalog Number 04625374160

Device Problem Low Test Results (2458)

Patient Problems Gastrointestinal Hemorrhage (4476); Insufficient Information (4580)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer.The reporter returned 1 test strip for investigation where it was tested using a retention meter and retention controls.Testing result (qc range = 2.1 - 3.3 inr): qc 1: 3.0 inr.The obtained qc value was within the allowed range of the used combination strip lot - qc lot.The measurement was without an error message.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 inr results with coaguchek xs meter serial number (b)(4) at the time of a "recent bleed situation." there was also a discrepant low result when compared to an unknown laboratory method.The bleed was reportedly detected after a scheduled colonoscopy.The patient was reportedly told the colonoscopy did not cause the bleed; the patient was told the bleed was from a different medical condition but the patient declined to provide the actual condition.Additional testing was set up due to the bleed.On (b)(6) 2021 the result from the meter at 12:20 p.M.Was reportedly 1.9 inr.The result from the laboratory at 3:30 p.M.Was reportedly 2.5 inr.The patient was reportedly treated with 10 mg of vitamin k based on the lab result of 2.5 inr which was believed to be correct.The patient¿s therapeutic range is allegedly 2.0-3.0 ir and she allegedly tests twice a month.The patient declined to provide further information.This mdr is being submitted in an abundance of caution.

• 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: 13291593
• MDR Text Key: 289083751
• Report Number: 1823260-2022-00162
• 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: 01/19/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 52333121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/19/2022
• 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: OTHER UNSPECIFIED MEDICATIONS; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 86 KG