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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

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

The initial reporter alleged a questionable inr result from coaguchek vantus meter serial number (b)(4).The patient is in the hospital for a saddle pulmonary embolism (pe); a large blood clot in the main pulmonary artery.On (b)(6) 2022 the meter result at 11:25 a.M.Was reportedly 2.2 inr.No changes were reportedly made to the patient¿s warfarin dose based on this result.On (b)(6) 2022 the patient reportedly experienced shortness of breath and passed out; the patient was taken to the hospital via ambulance.On (b)(6) 2022 the result from an unknown laboratory method at 11:47 a.M.Was reportedly 1.57 inr.The patient reportedly had a cat scan that diagnosed the saddle pe.The patient reportedly was treated with a heparin drip.The patient¿s therapeutic range prior to the event was allegedly 2 ¿ 3 inr.Following the event, the patient¿s therapeutic range was allegedly changed to 2.5 ¿ 3.5 inr.The patient allegedly tests every 2 weeks.The patient is reportedly still in the hospital in stable condition.

Manufacturer Narrative

The device code and an evaluation code were updated.The customer did not return any product.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: 13937675
• MDR Text Key: 288095490
• Report Number: 1823260-2022-00888
• 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: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/23/2022
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 177 KG