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 Transient Ischemic Attack (2109)

Event Date 06/17/2022

Event Type  Injury  

Event Description

We received an allegation that coaguchek xs meter serial number (b)(4) was "not reading strips" and was giving "errors" when the test strip was inserted.The reporter was unable to specify what error message was received and there are no strips remaining.During the attempt to troubleshoot the errors, it was mentioned that the patient reportedly had a "small stroke" requiring hospitalization on (b)(6) 2022.The patient had allegedly been receiving error messages on the meter and had run out of test strips prior to the hospitalization.The patient¿s therapeutic range is reportedly 2.0 ¿ 3.0 inr with an alleged testing frequency of weekly (if non-therapeutic) and every 2-3 weeks (if therapeutic).On (b)(6) 2022 the result from the meter was reportedly 2.0 inr.The patient does not remember if any coumadin dose adjustments were made.On (b)(6) 2022 the result from the meter was reportedly 1.5 inr.The patient does not think the coumadin dose was adjusted as she has allegedly been on the same dosage of 10 mg for "at least 6 months." the patient did not test on the meter after the result on (b)(6) 2022 as she was reportedly out of test strips due to the error messages; she had allegedly ordered the test strips but they had not yet arrived.On (b)(6) 2022 the result from an unknown laboratory method upon admission was reportedly 3.18 inr.The doctors reportedly thought the patient had a mild stroke or a complex migraine.Allegedly, the patient did not receive any treatment.The patient¿s coumadin was reportedly held or decreased the first day in the hospital and then kept at the same dose afterwards.Nothing was reportedly seen on the computed tomography (ct) brain scan or the magnetic resonance imaging (mri) that was performed.The patient was discharged on (b)(6) 2022 with an alleged laboratory result by an unknown method of 2.65 inr.On (b)(6) 2022 the laboratory result by an unknown method was reportedly 1.4 inr and the patient¿s coumadin dose was allegedly increased to 11 mg.The patient¿s left side is allegedly still weak and the patient reportedly has memory fogs and is wobbly.The patient had a follow up appointment with a neurologist.The neurologist reportedly stated the patient¿s "small stroke" was labeled as a transient ischaemic attack (tia) or a complex migraine.The neurologist allegedly thinks that if this was a tia or migraine the patient would have regained all function back, but as her left side is still weak, the neurologist reportedly thinks "something" was missed on the ct and mri scans.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Occupation is patient/consumer.The operator manual instructs: "if you see an error message, first try to correct the problem using the solution described below.If the problem persists, call roche customer support center at (b)(4), monday through friday from 7 am to 11 pm est." the meter and test strips were requested for investigation, however, there are no test strips remaining.No product has been received at this time.If any 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.

Manufacturer Narrative

The meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.5 inr, qc 2: 5.5 inr, qc 3: 5.5 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, however, the meter's time and date were set incorrectly.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: 15252583
• MDR Text Key: 298166282
• Report Number: 1823260-2022-02493
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/08/2022
• 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: AJOVY.; BUTEMIDE.; CALCIUM.; CLONAZEPAM.; ENTRESTO.; HYDROXOZIDE.; JANTOVEN.; LEVOTHRYOXINE.; LUNESTA.; METOPROLOL.; MULTIVITAMIN.; PRAMIPIXOLE.; PRISTIQ.; WELBUTRIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 86 KG