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

Catalog Number 04625358003

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

Patient Problems Intracranial Hemorrhage (1891); Movement Disorder (4412); Speech Disorder (4415)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer (patient's husband).The meter and test strips were requested for investigation, however, the test strips are no longer available to return.The meter was returned for investigation.Relevant retention test strips (lot 51508710) were measured with the returned meter with a high level control sample: testing results (qc range: 2.6 - 3.2 inr): qc 1: 2.9 inr qc 2: 3.0 inr qc 3: 2.9 inr all inr values were within the specified target ranges, confirming the functionality of the complained coaguchek meter.No error messages occurred.The returned customer material and retention material comply with the specification.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.

Event Description

We received an allegation of questionable inr results which reportedly contributed to a light brain hemorrhage and hospitalization for 1 patient testing with coaguchek xs meter serial number#: (b)(4).The reporter stated the event occurred on either (b)(6) 2021 or (b)(6) 2021.The results from the coaguchek xs meter were reported to be within the patient's therapeutic range.The patient¿s therapeutic range was requested but was not provided.The reporter only provided a target value of 2.5 inr.On either (b)(6) 2021 or (b)(6) 2021 the patient reportedly felt "ill" and the patient was reportedly taken to the hospital by ambulance.At the hospital the patient¿s result was reportedly 4.4 inr or 4.5 inr.The reporter could not remember the exact result.The patient reportedly had a ct scan where a light brain hemorrhage was identified.The patient reportedly had an operation to remove the hemorrhage and stop the bleeding.The patient was reportedly in the hospital for 14 days.Following the patient¿s release from the hospital, she reportedly started bridging with marcumar as advised by the hospital.The patient is reportedly currently undergoing cognitive and physical therapy due to issues with amnesic aphasia and issues related to walking properly.The patient¿s husband stated that apart from that, the patient is reportedly feeling fine and her inr is currently within the expected range.The reporter did not provide any specific inr results leading up to the event.On review of the returned meter memory, the last result prior to the alleged date of event was 2.6 inr on (b)(6) 2021.Additional information was requested, but has not been received at this time.This information includes: whether there were any medication adjustments based on meter results leading up to the event further details related to therapy at the hospital (e.G.Medications, bridging, marcumar dosage changes).The cause of the light brain hemorrhage and bleeding this mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Section a2, age was updated.Section a4, weight was updated.Section b7 was updated.Based on information obtained from the returned meter, the test strip lot number used at the time of the event could be determined.Sections d1, d4 catalog number, d4 lot number and d4 udi# were updated.Section d10 was updated.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12910326
• MDR Text Key: 286838417
• Report Number: 1823260-2021-03546
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358003
• Device Lot Number: 515087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2021
• 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: CONCOR; FALITHROM; MARCUMAR; UNSPECIFIED PAINKILLERS ¿ AS NEEDED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 74 KG