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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

A replacement product was sent.The test strips were requested but will not be available as they were all used up.The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: (b)(4) inr.Qc 2: (b)(4) inr, qc 3: (b)(4) 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 results alleged by the customer were observed in the meter¿s patient result memory.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.The investigation did not identify a product problem.The cause of the event could not be determined.The reporter is the patient's wife.

Event Description

We received an allegation of questionable inr results from a coaguchek xs meter with serial number (b)(4) that led to a bleeding event requiring blood transfusion and hospitalization.On (b)(6) 2021, the patient was reported to have undergone cholecystectomy after being diagnosed with gallstone pancreatitis.On (b)(6) 2021 at 9:16 am, the meter result was 2.5 inr.It was reported that the patient's warfarin dosage was changed based on this meter result.No details were provided on the actual changes made.On the same day, the reporter stated that the patient developed right-sided pain and did not feel well.His blood pressure was taken but a result was not obtained.It was assumed that the blood pressure "was too low to read".The patient was then brought to the emergency room.The laboratory result at 3:45 pm was reportedly 3.3 inr.The patient was reportedly hospitalized for one week and suffered a lot of blood loss due to internal bleeding.Oozing was reportedly noted on the gallbladder surgery site.Warfarin was put on hold and the patient was given intravenous vitamin k.He also reportedly required multiple blood transfusions (5 to 10 units).The reporter stated that the patient's inr was monitored through laboratory testing.The reporter states that the physician felt that the warfarin was a factor in the patient developing internal bleeding.The patient's overall health was reported to be fair.The patient's current condition was described to be "still dealing with pain." his condition is being monitored at home.The therapeutic range is 2.0 - 3.0 inr and testing is performed every two weeks.

• 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: 13367656
• MDR Text Key: 284881898
• Report Number: 1823260-2022-00221
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Date Manufacturer Received: 12/30/2021
• 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: LAMOTRIGINE; METOPROLOL; SODIUM; WARFARIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male