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

Catalog Number 07671687170

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

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs meter with unknown serial number compared to an unknown laboratory method.On (b)(6) 2022 at 6:00 a.M.The patient had a meter result of 2.2 inr while at 7:30 a.M.The lab result was 2.9 inr.The patient's therapeutic range was not provided.

Manufacturer Narrative

Initial reporter 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.Per product labeling: coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.

Manufacturer Narrative

The test strips were returned for investigation.The returned test strips were measured on reference meters with a high-level control sample: testing results (qc range: 2.7 - 3.3 inr): qc 1: 2.9 inr qc 2: 2.9 inr qc 3: 2.8 inr all inr values were within the specified target ranges, confirming the functionality of the complained coaguchek test strips.No error messages occurred.Returned customer material and retention material comply with the specification.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d9 and h3 have been updated.

• 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: 16070767
• MDR Text Key: 308472543
• Report Number: 1823260-2022-04234
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/06/2023

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: 10/31/2023
• Device Catalogue Number: 07671687170
• Device Lot Number: 60124819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/06/2023
• 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
• Patient Sex: Male