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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The meter serial number was (b)(6).The meter has been requested for return.No test strips were available to be returned.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.E3 - occupation was patient/consumer.

Event Description

There was an allegation of questionable results from coaguchek xs meter.At 1023 pm, the result was 7.0 inr.At 1027, the result was 5.2 inr.The customer used a different finger for each test.The therapeutic range was 2.0-3.0 inr and the customer tests weekly.The customer started a new medication of tylenol.

Manufacturer Narrative

Only the meter was returned for investigation.It was tested with retention strips and retention roche qc level 1 and level 2 controls.Level 1 testing results (qc range = 1.1 ¿ 1.4 inr): qc 1: 1.3 inr.Level 2 testing results (qc range = 2.4 ¿ 3.6 inr): qc 2: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The result of 7.0 inr mentioned by the customer was not observed in the meter¿s patient result memory.

• 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
• MDR Report Key: 18356476
• MDR Text Key: 331198158
• Report Number: 1823260-2023-04101
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: 12/22/2023

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELECOXIB.; DULOXETINE.; FAMOTIDINE.; FOLIC ACID.; FUROSEMIDE.; LISINOPRIL.; METOPROLOL.; MONTELUKAST.; OMEPRAZOLE.; PRAVASTATIN.; PREGABALIN.; WARFARIN.
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 80 KG