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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

There was an allegation of questionable inr results for a patient testing with a coaguchek xs pro meter, serial number (b)(4).The patient¿s doctor reportedly suggested that the patient may have a gi (gastrointestinal) bleed.The patient¿s doctor reportedly noticed blood in the stool in the (b)(6) or (b)(6) 2021 timeframe.The date of event is an approximation.Results from the meter were reportedly: 3.3 inr on (b)(6) 2021 at 6:55 pm; 2.4 inr on (b)(6) 2021 at 2:24 am; 2.2 inr on (b)(6) 2021 at 1:05 am; 2.2 inr on (b)(6) 2021 at 8:50 pm; 2.0 inr on (b)(6) 2021 at 10:36 pm.The doctor reportedly wants to perform a colonoscopy and has concerns about the meter¿s accuracy.The patient reportedly took 7.5 mg of warfarin on tuesdays and thursdays and 5 mg the rest of the week.However, at some point in n(b)(6) or (b)(6) 2021, the patient's warfarin dosage was adjusted and they now take 5 mg of warfarin daily.The patient's therapeutic range is 2.0-3.0 inr and she tests bi-weekly.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Occupation is a patient/consumer.The meter and test strips were requested for investigation.The product has not been received at this time.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.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and controls.Testing results (qc range = 2.5 - 3.7 inr): qc 1: 3.1 inr.Qc 2: 3.1 inr.Qc 3: 3.1 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The results alleged by the customer were observed in the returned meter¿s memory.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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13118423
• MDR Text Key: 285064673
• Report Number: 1823260-2021-03940
• 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: 01/21/2022

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 51508621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/21/2022
• 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: LISINOPRIL; OMEPRAZOLE ER; PRAVASTATIN; PREVALITE POWDER; SODIUM BICARB; SODIUM TABLETS; TRULICITY; VITAMIN D2; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 77 KG