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

Catalog Number 04625374160

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

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number: (b)(4) compared to a laboratory using the neoplastin reagent.At 9:09 am, the meter result was 7.7 inr.An unknown test strip lot was used for the test.At 9:15 am, the meter result was 7.9 inr.An unknown test strip lot was used for the test.At 10:30 am, the result from the laboratory was 5.3 inr.On (b)(6) 2022 at 7:18 am, the meter result using test strip lot: 62216021 was 5.3 inr.The reagent on the back of the test strips is pink indicating the test strips have been compromised by exposure to humidity.At 8:30 am, the result from the laboratory was 3.7 inr.Customer's therapeutic range is 2.0-3.0 inr.The customer tests every two weeks.

Manufacturer Narrative

Occupation is patient/consumer.The test strips were requested for investigation.The product has not been returned.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.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin based laboratory method is compared to other laboratory methods." the investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.2 inr.Qc 2: 5.1 inr.Qc 3: 5.2 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.No error observed during investigation.

• 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: 16055101
• MDR Text Key: 308459677
• Report Number: 1823260-2022-04199
• Device Sequence Number: 1
• Product Code: GJS
• 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,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 62216021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2023
• 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
• Treatment: AMIODERONE; IRON; JANTOVEN; SPIRONACTILINE
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 75 KG