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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/17/2021

Event Type  Injury  

Event Description

We received an allegation of questionable inr results with coaguchek xs meter serial number (b)(4) resulting in the diagnosis of a blood clot.The patient went to the hospital because his thigh was hurting.The result from an unknown laboratory method was reportedly 1.7 inr.The result from the meter within "minutes" at 5:43 p.M.Was reportedly 2.7 inr.The patient was reportedly diagnosed with a blood clot on his front thigh via ultrasound.The patient was reportedly taken off of warfarin and put on a heparin iv.The patient reportedly left the hospital 24 hours later and was sent home with lovenox injections.The patient allegedly takes 5mg of warfarin daily.The patient¿s therapeutic range is reportedly 2-3 inr and tests once a month.

Manufacturer Narrative

Occupation is patient/consumer.The meter and 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

Occupation is patient/consumer.The meter and 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.".

Event Description

We received an allegation of questionable inr results with coaguchek xs meter serial number (b)(4) resulting in the diagnosis of a blood clot.The patient went to the hospital because his thigh was hurting.The result from an unknown laboratory method was reportedly 1.7 inr.The result from the meter within "minutes" at 5:43 p.M.Was reportedly 2.7 inr.The patient was reportedly diagnosed with a blood clot on his front thigh via ultrasound.The patient was reportedly taken off of warfarin and put on a heparin iv.The patient reportedly left the hospital 24 hours later and was sent home with lovenox injections.The patient allegedly takes 5mg of warfarin daily.The patient¿s therapeutic range is reportedly 2-3 inr and tests once a month.

Manufacturer Narrative

The meter was returned for investigation.The test strips were not returned.The meter was tested with retention test strips and liquid qc of a high level.Testing results (qc range: 2.6 - 3.2 inr): qc 1: 3.0 inr qc 2: 3.0 inr qc 3: 3.0 inr the obtained qc results were in the allowed range.No error messages occurred during investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 13501491
• MDR Text Key: 286339256
• Report Number: 1823260-2022-00338
• 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: 04/04/2022

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: 04/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49682521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 02/09/2022
• 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: WARFARIN - DAILY
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 150 KG