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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/09/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is a patient/consumer.The meter and test strips were requested for investigation.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.There were 3 test strips of lot 49682521 tested for the investigation.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr.Qc 2: 2.9 inr.Qc 3: 2.9 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

We received an allegation questioning inr results from a coaguchek xs meter serial number (b)(4) for one patient reportedly bridging with lovenox after a planned medical procedure.The patient¿s regular warfarin dose was 5mg for 5 days and 2.5 mg for 2 days.On (b)(6) 2021, the patient had a pre-scheduled heart ablation procedure.The last inr result from the meter was reportedly 2.0 inr on (b)(6) 2021.On (b)(6) 2021, the patient reportedly had a meter result of 1.1 inr.The patient was reportedly advised by the doctor to start bridging with an injection of lovenox every 12 hours and continue her regular warfarin dose of 5mg for 5 days and 2.5 mg for 2 days.Following this advice, the following results were obtained on the meter: on (b)(6) 2021 1.4 inr 10:44am.On (b)(6) 2021 1.7 inr on her meter at 11:39am.On (b)(6) 2021 patient obtained a 1.6 inr on her meter at 4:40pm.On (b)(6) 2021 the meter batteries were replaced and the date and time were not reset by the user in the meter.During the call, the reporter was instructed on how to set the meter to the correct date and time per product labeling.On (b)(6) 2021 the patient reportedly had a bleed at the ablation site.The patient¿s husband reportedly called the on-call nurse and was told to apply direct pressure for 10 minutes which reportedly stopped the bleeding and no further medical treatment was needed.On (b)(6) 2021 at 3:34 pm, the patient reportedly had an inr result on the meter of 1.8 inr.The patient was reportedly advised by the doctor to stop the lovenox injections and continue with her regular warfarin dose and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 2.0 inr from the meter.The patient was reportedly advised to continue the normal warfarin dose and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 1.5 inr from the meter.The patient was reportedly advised by the doctor to increase the warfarin dose to 5 mg daily and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 1.6 inr from the meter.The patient was reportedly advised to continue the warfarin dose of 5 mg daily.The reported inr results from the meter have been verified in the returned meter memory.The patient¿s therapeutic range was 2.0 - 3.0 and the patient normally tests every 2 weeks.

Event Description

We received an allegation questioning inr results from a coaguchek xs meter serial number (b)(4) for one patient reportedly bridging with lovenox after a planned medical procedure.The patient¿s regular warfarin dose was 5mg for 5 days and 2.5 mg for 2 days.On (b)(6) 2021, the patient had a pre-scheduled heart ablation procedure.The last inr result from the meter was reportedly 2.0 inr on (b)(6) 2021.On (b)(6) 2021, the patient reportedly had a meter result of 1.1 inr.The patient was reportedly advised by the doctor to start bridging with an injection of lovenox every 12 hours and continue her regular warfarin dose of 5mg for 5 days and 2.5 mg for 2 days.Following this advice, the following results were obtained on the meter: on (b)(6) 2021 1.4 inr 10:44am.On (b)(6) 2021 1.7 inr on her meter at 11:39am.On (b)(6) 2021 patient obtained a 1.6 inr on her meter at 4:40pm.On (b)(6) 2021 the meter batteries were replaced and the date and time were not reset by the user in the meter.During the call, the reporter was instructed on how to set the meter to the correct date and time per product labeling.On (b)(6) 2021 the patient reportedly had a bleed at the ablation site.The patient¿s husband reportedly called the on-call nurse and was told to apply direct pressure for 10 minutes which reportedly stopped the bleeding and no further medical treatment was needed.On (b)(6) 2021 at 3:34 pm, the patient reportedly had an inr result on the meter of 1.8 inr.The patient was reportedly advised by the doctor to stop the lovenox injections and continue with her regular warfarin dose and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 2.0 inr from the meter.The patient was reportedly advised to continue the normal warfarin dose and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 1.5 inr from the meter.The patient was reportedly advised by the doctor to increase the warfarin dose to 5 mg daily and test again in a couple of days.On (b)(6) 2021, the patient reportedly had an inr result of 1.6 inr from the meter.The patient was reportedly advised to continue the warfarin dose of 5 mg daily.The reported inr results from the meter have been verified in the returned meter memory.The patient¿s therapeutic range was 2.0 - 3.0 and the patient normally tests every 2 weeks.

Manufacturer Narrative

Occupation is a patient/consumer.The meter and test strips were requested for investigation.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.There were 3 test strips of lot 49682521 tested for the investigation.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr.Qc 2: 2.9 inr.Qc 3: 2.9 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 12857468
• MDR Text Key: 286340230
• Report Number: 1823260-2021-03439
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49682521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Date Manufacturer Received: 10/29/2021
• 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: WARFARIN 5MG
• Patient Age: 79 YR
• Patient Sex: Female