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

Catalog Number 04625315160

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

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs pst meter unknown serial number compared to coaguchek xs meter serial number (b)(4).On (b)(6) 2022 at 10:30 a.M.The patient had a lab result of 2.2 inr while at 10:45 a.M.The patient meter result was 1.5 inr.The patient's warfarin dose was increased.The patient's therapeutic range was 2.5-3.5 inr.The patient's interval of testing is every 4-7 days.

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.0 inr, qc 2: 5.1 inr, qc 3: 5.2 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 results alleged by the customer were observed in the meter¿s patient result memory.The investigation did not identify a product problem.The cause of the event could not be determined.The patient's hematocrit is 35%.Per product labeling, hematocrit ranges between 25-55 % do not significantly affect results.Therefore, the patient's hematocrit level is within the acceptable range.The patient used the same finger for the other measurement.According operator manual, for a second measurement a new puncture of a different finger is mandatory.

• 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: 16034185
• MDR Text Key: 308447627
• Report Number: 1823260-2022-04157
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 04625315160
• Device Lot Number: 57261211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DULOXETINE,; LASIX,; OMEPRAZOLE.; TYLENOL,; WARFARIN,
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 67 KG