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

Catalog Number 04625315160

Device Problem High Test Results (2457)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to a laboratory using the stago neoplastin reagent.Patient 1: tested using meter (b)(4) and test strip lot 50323014.On (b)(6) 2021 at 2:00 pm, the meter result was >8.0 inr.At 2:20 pm, the result from the laboratory was 5.8 inr.The patient's therapeutic range is 2.0-3.0 inr.Patient 2: tested using meter (b)(4) and test strip lot 52818417 with expiration date 30-sep-2022.On (b)(6) 2021, the meter result was >8.0 inr.The result from the laboratory within one hour was 6.01 inr.The patient's therapeutic range is 3.0-4.0 inr.Patient 3: tested using meter (b)(4) and test strip lot 53666811 with expiration date 30-nov-2022.On (b)(6) 2021, the meter result was 6.2 inr.The result from the laboratory within 1.5 hours and the result was 4.19 inr.The patient's therapeutic range is 2.5-3.5 inr.

Manufacturer Narrative

The test 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.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 strip lot 53666811 was provided for investigation where it was tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr.Qc 2: 3.0 inr.Qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13118098
• MDR Text Key: 288876818
• Report Number: 1823260-2021-03932
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 04625315160
• Device Lot Number: 50323014, 52818417, 53666811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/24/2022
• 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: PATIENT1-HEPARIN