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

Catalog Number 04625315160

Device Problems Circuit Failure (1089); High Test Results (2457)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for two patients tested with the coaguchek xs plus meter with serial number uq0134786 compared to an unknown laboratory method.  the reporter initially called because the meter reportedly gives a frequent error when it is moved even for just a bit during testing.The reporter stated that she has to move the meter away from the patient's finger so they can apply gauze to the finger and that is when the error occurs.The error reportedly does not occur if the meter is not moved.Upon the reproduction of the error during the call, errors e-403 (test strips with lot number 58526211 was used) and e-405 were received.The reporter stated that error e-405 was received at times.During the call, the reporter also stated that the meter results were higher when compared to the laboratory.Patient 1: on (b)(6) 2022: the meter result was 3.9 inr.The laboratory result was 2.6 inr.On (b)(6) 2022: the meter result was 3.8 inr.The laboratory result was 2.7 inr.On an unknown date; the meter and laboratory results were 3.7 inr vs.2.8 inr (the source of the results was requested but not provided).The time interval between the tests is unknown.The therapeutic range is 2.5 inr ¿ 3.5 inr.The reporter stated that the patient is not always compliant and does not always come to the clinic as frequently as they would like the patient to.Patient 2: on an unknown date: the meter result was 3.6 inr.The laboratory result was 2.5 inr.On an unknown date: the meter result was 4.3 inr.The laboratory result was 2.8 inr.The time interval between the tests is unknown.The therapeutic range is 2.5 inr - 3.5 inr.The reporter stated that they have tried several different bottles of strips with the same issue.The following lot numbers were reported: lot number 58526211 with an expiration date of 31-jul-2023.Lot number 54145311 with an expiration date of 30-nov-2022.Lot number 60124512 with an expiration date of 31-aug-2023.Lot number 53666811 with an expiration date of 30-nov-2022. .

Manufacturer Narrative

The reporter's meter and test strips with lot number 63311412 were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr, qc 2: 5.1 inr, qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's alleged result of 3.8 inr on (b)(6) 2022 was not observed in the meter result memory.The most recent result of 3.8 inr was on (b)(6) 2022 according to the meter result memory.The customer's alleged result of 3.5 inr on (b)(6) 2022 was not observed in the meter's patient result memory.The closest result of 3.5 inr to this date was on (b)(6) 2022 according to the meter result memory.The customer's alleged result of 3.9 inr on (b)(6) 2022 was not observed in the meter result memory.However, a result of 3.9 inr on (b)(6) 2022 was observed in the meter result memory.The customer also alleged receiving results of 3.6 inr and 4.3 inr.However, the customer was unable to provide dates for these results.Therefore, the investigation was unable to confirm these results as this meter has hundreds of stored results.All other alleged results by the customer were observed in the meter result memory.The reporter initially called because the meter reportedly gives a frequent error when it is moved even for just a bit during testing.Product labeling states: "operating conditions - to ensure that the meter functions properly, please observe the following guidelines: when testing, place the meter on a level, vibration-free surface, or hold it so it is roughly horizontal." the customer received errors e-403 and e-405.Product labeling states: "e-403 a dosing error was detected.Check your procedure and repeat test, using a new test strip." "e-405 a measurement error occurred.Check your procedure and repeat test, using a new test strip." 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 method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16063627
• MDR Text Key: 306710744
• Report Number: 1823260-2022-04223
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625315160
• Device Lot Number: 63311412, 58526211, 54145311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• 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: REFER TO THE ATTACHMENT IN THE MEDWATCH.
• Patient Age: 59 YR
• Patient Sex: Female