MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME TEST STRIPS

Catalog Number 07671687019

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

Two test strip lots were used with the coaguchek inrange system: 70302122, expiration date 31-oct-2024 and 71519012, expiration date 31-dec-2024.It is not known which test strip lot was used for which test.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 complained of discrepant inr results for 1 patient tested with a coaguchek inrange meter and a coaguchek xs plus meter compared to an unknown laboratory method.This medwatch will cover the coaguchek inrange system.Refer to medwatch with a1 patient identifier (b)(6) for information on the coaguchek xs plus system.On (b)(6) 2023 the result from the inrange meter was 4.2 inr.The result from the xs plus meter was 4.1 inr.The result from the laboratory from a sample drawn at the same time was 2.1 inr.On (b)(6) 2023 the result from the inrange meter was 4.8 inr.The result from the xs plus meter was 4.5 inr.The result from the laboratory from a sample drawn at the same time was 3.5 inr.On (b)(6) 2023 the result from the inrange meter was 4.1 inr.The result from the xs plus meter was 3.9 inr.The result from the laboratory from a sample drawn at the same time was 2.9 inr.The patient¿s therapeutic range was not provided.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The coaguchek inrange meter serial number was (b)(6).The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17876226
• MDR Text Key: 324982259
• Report Number: 1823260-2023-03195
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07671687019
• Device Lot Number: 70302122, 71519012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/10/2023
• 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: OMEPRAZOLE.; PREDNISOLONE.