MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME TEST STRIPS

Catalog Number 07762798003

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

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The 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.

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs pt pst meter serial number (b)(4).On (b)(6) 2022 at 4:17 p.M.The patient had an initial meter result of 4.2 inr, while re-test at 4:20 p.M.The meter result was 5.4 inr and while re-test again at 4:33 p.M.The meter result was 5.5 inr.These measurements were done using the test strip lot number: 58517214.The patient bought new coaguchek xs pt pst test strips and measured again.On (b)(6) 2022 at 4:59 p.M.The patient had a meter result of 3.6 inr.This measurement was done with using the test strip lot number: 62681812.The patient's therapeutic range was 2.5-3.2 inr.

Manufacturer Narrative

Only test strips with lot number of 58517214 were provided for investigation where they were measured in comparison with the current test strip master lot.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Testing results: master lot: 2.0 inr.The returned strips: 1.9 inr.Master lot: 2.8 inr.The returned strips: 2.6 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.Visual analysis of test strips revealed scratches on the gold side.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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: 16060055
• MDR Text Key: 308484915
• Report Number: 1823260-2022-04207
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 07762798003
• Device Lot Number: 58517214, 62681812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; MARCUMAR; NEBIVOLOL; PARACETAMOL; PRAVASTATIN
• Patient Age: 59 YR
• Patient Sex: Female