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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Pulmonary Embolism (1498)

Event Date 10/11/2021

Event Type  Injury  

Event Description

It was alleged that a patient was hospitalized for a pulmonary embolism (pe) and blood clots while using coaguchek xs meter serial number (b)(4).On (b)(6) 2021 the result from the meter was (b)(6) inr, and the patient was reportedly advised to take 2 mg of warfarin on monday, wednesday and friday and (b)(6) mg tuesday, thursday, saturday, and sunday.This was the last meter result prior to the alleged hospitalization.On (b)(6) 2021, the patient reportedly went to the hospital for pain in the legs and was admitted for two blood clots in the left leg, two baseball-sized cellulitis balls behind the left knee and thigh, and one pe in each lung.The inr result from the hospital is unknown but it was reportedly below the therapeutic range.There was no meter result on (b)(6) 2021.The patient reportedly received heparin, antibiotics, and potassium and the patient's warfarin was held for 3 days while in the hospital.The antibiotic was allegedly for cellulitis and was taken starting (b)(6) 2021 and ended on (b)(6) 2021.The potassium was allegedly for dehydration and leg cramps.The patient was reportedly released from the hospital and returned home on (b)(6) 2021.The patient reportedly was advised to take 6 mg of warfarin for three days after release from the hospital.The patient's therapeutic range is 2.0-3.0 inr.

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation, however, there are no test strips remaining to return.The patient¿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)(6) inr.Qc 2: (b)(6) inr.Qc 3: (b)(6) inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation, however, there are no test strips remaining to return.The patient¿s meter was provided for investigation where it was tested using retention strips and retention controls.(b)(6).The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.

Event Description

It was alleged that a patient was hospitalized for a pulmonary embolism (pe) and blood clots while using coaguchek xs meter serial number (b)(4).On (b)(6) 2021 the result from the meter was (b)(6) inr, and the patient was reportedly advised to take 2 mg of warfarin on monday, wednesday and friday and (b)(6) mg tuesday, thursday, saturday, and sunday.This was the last meter result prior to the alleged hospitalization.On (b)(6) 2021, the patient reportedly went to the hospital for pain in the legs and was admitted for two blood clots in the left leg, two baseball-sized cellulitis balls behind the left knee and thigh, and one pe in each lung.The inr result from the hospital is unknown but it was reportedly below the therapeutic range.There was no meter result on (b)(6) 2021.The patient reportedly received heparin, antibiotics, and potassium and the patient's warfarin was held for 3 days while in the hospital.The antibiotic was allegedly for cellulitis and was taken starting (b)(6) 2021 and ended on (b)(6) 2021.The potassium was allegedly for dehydration and leg cramps.The patient was reportedly released from the hospital and returned home on (b)(6) 2021.The patient reportedly was advised to take 6 mg of warfarin for three days after release from the hospital.The patient's therapeutic range is 2.0-3.0 inr.

• 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: 12902322
• MDR Text Key: 285360258
• Report Number: 1823260-2021-03537
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/09/2021
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/30/2021
• 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: VITAMIN B; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 141 KG