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

Catalog Number ASKU

Device Problems Circuit Failure (1089); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535); Loss of Data (2903)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's meter was requested for investigation and replacement product was sent to the customer.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.Medwatch field reporter.Occupation - the occupation is patient/consumer.

Event Description

It was reported that a patient received a questionable value from coaguchek xs meter serial number (b)(4).The patient's therapeutic range is unknown.When calling on (b)(6) 2022, the customer observed a "5" on the meter display after trying to test.It is not known if this was an error 5 or if it was an actual measurement result.The meter did not display "5.0".The test strip that was used was not filled to the very top with blood.The customer was advised that the back of a used test strip needs to be filled to the very top of the back channel with blood.During the call on (b)(6) 2022, the customer tested again and received a result of 2.4 inr.

Manufacturer Narrative

The meter was returned for investigation.The meter could be powered on with fresh retention batteries.A full display check was performed and there were no missing or faded segments.No display issues were observed.The returned meter was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr qc 2: 5.1 inr qc 3: 5.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer alleged seeing a "5" on the display.A review of the meter's error log revealed error 5.This error occurs when the applied sample volume is insufficient.

• 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: 15782582
• MDR Text Key: 307786011
• Report Number: 1823260-2022-03592
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• 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