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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Lack of Maintenance Documentation or Guidelines (2971)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4).On (b)(6) 2022 at around 1:45 p.M., the meter result was 1.8 inr.At around 1:45 p.M, the meter result was 2.3 inr.At around 1:45 p.M, the meter result was 2.6 inr.At around 1:45 p.M, the meter result was 2.5 inr.The patient¿s therapeutic range and testing frequency were not provided.

Manufacturer Narrative

Occupation is patient/consumer the meter and strips were requested for investigation.Replacement product was sent.The customer's meter and strips were returned for investigation.However, the customer's returned strips had no available test strips for investigation.Therefore, the customer's returned meter was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 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.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.

• 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: 15826789
• MDR Text Key: 307710897
• Report Number: 1823260-2022-03686
• 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
• Report Date: 11/18/2022

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: 07/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 58526222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/18/2022
• 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: ALBUTEROL ATROVENT.; ALDACTONE.; ENTRESTO.; FARXIGA.; LASIX.; OXYGEN.; PRAVASTATIN.; TOPROL.; TRELEGY.; WARFARIN.
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 82 KG