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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: occupation is patient/consumer.The test strips were requested for investigation.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: 5.7 inr.Qc 2: 5.7 inr.Qc 3: 5.7 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(4).The meter result using an unknown test strip lot was 3.4 inr.The customer tested again using an unknown test strip lot and the meter result was 2.6 inr.Customer repeated the meter test again using test strip lot 62682421 and the result was 3.5 inr.Customer's therapeutic range is 2.5-3.5 inr.The customer tests every two weeks.

• 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: 16055108
• MDR Text Key: 308446301
• Report Number: 1823260-2022-04198
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2022

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: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 62682421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• 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: ALENDRONATE FOSAMAX; AMOXICILLIN; CALCIUM; KETOROLAC; LANTOPROST; MAGNESIUM; METOPROLOL; PREDNISONE; SIMBRINZA; TRAMADOL; TYLENOL; VITAMIN D; WARFARIN
• Patient Age: 84 YR
• Patient Sex: Female