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

Catalog Number 04625374160

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The coaguchek xs meter serial number was (b)(6).The product was 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.The reporter initially called due to an error 6.Product labeling states "error 6: error: test strip interference - the test strip was touched or removed during the test.Solution: turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Do not touch or remove the test strip when a test is in progress.Note: for meters with serial number (b)(6) and lower: in rare cases, 'error 6' may indicate extremely high coagulation times (> 10 inr, < 5% quick).If 'error 6' is displayed repeatedly, please contact your physician without delay." on a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.Section e3 - occupation: patient/consumer.

Event Description

We received an allegation of a questionable inr result for one patient tested with the coaguchekxs meter.The reporter initially called because they received "error 6" twice.Error 6 is related to moving the test strip during the test.The patient was able to obtain a result.The initial meter result was 2.4 inr.The repeat meter result was 3.3 inr.  the time interval between the tests was requested but not provided.The patient's therapeutic range is 2.0 to 3.0 inr.   .

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18233859
• MDR Text Key: 329913458
• Report Number: 1823260-2023-03796
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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 Catalogue Number: 04625374160
• Device Lot Number: 66283721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/05/2024
• 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: TYLENOL FOR PAIN.