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

Catalog Number 04625374160

Device Problem Human-Device Interface Problem (2949)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The customer¿s products have been requested for return.The investigation is ongoing.Reporter occupation was lay user/patient.

Event Description

The initial reporter stated on (b)(6) 2018 the patient could not test on coaguchek xs meter serial number (b)(4) due to an error message.The actual error message received could not be provided.No inr value was known for this date.On (b)(6) 2018, the result was 10.7 inr from the emergency room laboratory.Based on the laboratory result, the customer received a call on 04-dec-2018 to go to the emergency room.On (b)(6) 2018, the result was 10.7 inr from the emergency room laboratory.They gave him vitamin k orally, and then sent him home.On (b)(6) 2018, the result was 3.6 inr from the laboratory.The therapeutic range was 2.0 to 3.0 inr.The customer's testing interval was weekly.It was not known why the patient tested earlier than this interval.The patient did not seek medical advice nor an alternative testing method on (b)(6) 2018.No other inr measurement was performed that day.The laboratory measurement performed on (b)(6) 2018 with a result of 10.7 inr is above the therapeutic range and indicated an elevated bleeding risk.In the time frame between (b)(6) 2018 and (b)(6) 2018, fluctuations of inr result under treatment cannot be excluded.Therefore, the result from the meter on (b)(6) 2018 and the laboratory results on (b)(6) 2018 and (b)(6) 2018 would not be discrepant from a clinical aspect.No symptoms or/and signs of bleeding were alleged.The administered treatment with vitamin k orally is in line with the clinical procedures for management of anticoagulated patients with inr > 9.0 and no significant bleeding.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and quality controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 inr.Qc 2: 5.4 inr.Qc 3: 5.5 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The customer alleged an unknown error occurred on (b)(6)2018.The error report from the meter did not list any errors occurring in the year 2018.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10129131
• MDR Text Key: 199081694
• Report Number: 1823260-2020-01380
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 34521321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPART FLEX PEN NOVA; ASPIRIN; ATORVASTATIN; DIGOXIN; ESCITALOPRAM OXALATE; FAMOTIDINE; FUROSEMIDE; JANTOVEN; LANTUS; LEVOTHYROXINE SODIUM; METOPROLOL TARTRATE; TERAZOSIN HCL
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 91