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

Catalog Number	07797826160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable inr results for one patient tested on a coaguchek xs meter serial number (b)(4) compared to an unknown laboratory methodology.For each meter test, it was reported the patient used a new finger for sample collection.On (b)(6) 2022 and "around" 10:00 a.M., the patient¿s meter result was 6.1 inr.On (b)(6) 2022 and "around" 10:00 a.M., the patient¿s meter result was 5.9 inr with a different finger.On (b)(6) 2022 and at 1:30 p.M., the patient¿s laboratory result was 3.6 inr.On (b)(6) 2022 and at 13:12, the patient¿s meter result was >8.0 inr.On (b)(6) 2022 and at 13:15, the patient¿s meter result was 8.0 inr with a different finger.On (b)(6) 2022 and at 16:46, the patient¿s laboratory result was 4.7 inr.The patient¿s therapeutic range was 2.0-3.0 inr.The patient's testing frequency is every two weeks.
Additional Manufacturer Narrative
The meter and strips were requested for investigation.Replacement product was sent.The meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.It was reported the patient was on antibiotics.Product labeling states, "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr)." it was reported the patient was on lovenox.Product labeling states, "testing performed with the following in vitro spiked samples or native blood samples (for testing of triglycerides) indicated no significant effect on test results: low molecular weight heparins (lmwh) up to 2 iu anti-factor xa activity/ml." 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.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• 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: 14347446
• Report Number: 1823260-2022-01347
• Device Sequence Number: 20050116
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 07797826160
• Device Lot Number: 54974311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; ASPIRIN 81MG; ATENOLOL; ATORVASTATIN; CENTRUM COMPLETE MULTI-VITAMIN; CEPHALEXIN; FOLIC ACID; IMODIUM; LISINOPRIL; LOVENOX; OXYCODONE; UNSPECIFIED ANTIBIOTICS; VITAMIN D3; WARFARIN
• Patient Age: 79 YR
• Patient Sex: Female