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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The customer's meter and strips were requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Relevant retention test strips (lot 405010) were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.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 complained of discrepant inr results with coaguchek xs meter serial number (b)(4), compared to an unknown laboratory method.The result from the meter at 08:21 a.M.Was 2.9 inr.The result from the laboratory at the same time was 2.2 inr.The patient's therapeutic range is 2.0 - 3.0 inr.The customer had pain in their leg and foot and were admitted to the hospital.The pain in the leg was due to either gout, arthritis or old/new clots.It was not determined if the clot in the leg was an existing clot or a new clot.The customer did not report that a meter result contributed to the event.The customer is currently on lovenox.

• 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: 9627368
• MDR Text Key: 217661460
• Report Number: 1823260-2020-00195
• Device Sequence Number: 1
• Product Code: GJS
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 40501021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1