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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/13/2023

Event Type  Injury  

Event Description

We received an allegation that the coaguchek vantus meter may have contributed to a patient reportedly developing a deep vein thrombosis requiring hospitalization.The patient¿s therapeutic range was allegedly 2.0 ¿ 3.0 inr prior to the hospitalization and was reportedly changed to 2.5 ¿ 3.5 inr after the hospitalization.On (b)(6) 2023, the meter result was 1.6 inr.The patient allegedly reported this result to her physician and her warfarin dose was reportedly increased.On (b)(6) 2023, the meter result was 2.1 inr.The patient allegedly reported this result to her physician.There were reportedly no changes made to her warfarin dose.On (b)(6) 2023, the meter result was 1.5 inr.The patient allegedly reported this result to her physician and her warfarin dose was reportedly increased.On (b)(6) 2023, the meter result was 2.7 inr.The patient allegedly reported this result to her physician.There were reportedly no changes made to her warfarin dose.On (b)(6) 2023, the meter result was 3.1 inr.The patient allegedly reported this result to her physician.There were reportedly no changes made to her warfarin dose.On (b)(6) 2023, the patient allegedly went to the hospital as her leg "had a lot of swelling." the result from an unknown laboratory method was reportedly 2.3 inr.On (b)(6) 2023, the result from an unknown laboratory method was reportedly 2.4 inr.On (b)(6) 2023, the meter result was 2.7 inr.The result from an unknown laboratory method within 4 hours was reportedly 2.0 inr.The patient¿s warfarin dose was reportedly increased based on the laboratory result.On (b)(6) 2023, the meter result was 3.4 inr.The result from an unknown laboratory method within 4 hours was reportedly 2.9 inr.The patient was allegedly admitted to the hospital from on (b)(6) 2023.The patient was reportedly found to have a deep vein thrombosis in her left thigh.While in the hospital the patient was reportedly on a heparin drip and was taking warfarin.A doppler ultrasonography was allegedly performed on both legs for a comparison study.Reportedly, the patient did not receive any other treatment while in the hospital and is "stable and well.".

Manufacturer Narrative

Section e3: occupation is patient/consumer.The coaguchek vantus meter serial number was (b)(6).The meter and test strips were requested for investigation, however, the test strips in use at the time of the event have been discarded and will not be returned.The meter was received for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.4- 3.6 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.8 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 alleged results were observed in the meter¿s patient result memory.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." 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18022846
• MDR Text Key: 326795530
• Report Number: 1823260-2023-03443
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 64708110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• 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: ALLOPURINOL.; ENALAPRIL [VASOTEC].; HYDROXYCHLOROQUINE.; WARFARIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic