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	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable inr results for one patient tested on two coaguchek xs meters compared to an unknown laboratory methodology.On (b)(6) 2021 and at 10:26, the patient's inr result with coaguchek xs meter serial number (b)(4) and test strip lot 53224317 was 8.0 inr.Within four hours, the patient's laboratory result was 4.8 inr.The patient withheld coumadin based on the 4.8 inr result.On (b)(6) 2021, the patient's inr result with an unknown coaguchek meter and an unknown test strip lot was 8.0 inr.Within four hours, the patient's laboratory result was 5.2 inr.The patient's therapeutic range was 2.0-3.0 inr.The patient's testing frequency was reported "as needed.".
Additional Manufacturer Narrative
The strips were requested for investigation.Replacement product was sent.The product has not been received at this time and is not expected to be returned.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.The patient was taking antibiotics.Per product labeling, when other medications, like antibiotics, are taken simultaneously it can lead to either an increase or a decrease in prothrombin time (inr).Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods.".
Additional Manufacturer Narrative
The strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 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.Medwatch fields d9 and h3 were updated.

• 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: 13094736
• Report Number: 1823260-2021-03890
• Device Sequence Number: 4054667
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 09/30/2022
• Device Catalogue Number: 07797826160
• Device Lot Number: 53224317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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: CEFTRIAXONE; COLACE; COUMADIN; HYDROCODONE; LASIX; METOPROLOL; MIRALAX; PANTOPRAZOLE; POTASSIUM CHLORIDE; TYLENOL
• Patient Age: 71 YR
• Patient Sex: Female