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

Model Number XS PST

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

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

The initial reporter occupation is patient/consumer.For the battery error message, product labeling states: "error: battery.The battery level is too low.Solution: replace the batteries.See the batteries section of this manual." for the results in seconds unit of measure: the meter is provided to u.S.Customers pre-set to the measuring unit inr.There are two additional measuring units on the meter: %quick (%q) and seconds (sec).In the u.S., the most accepted unit of measure is inr.Roche has communicated to all impacted customers instructions on how to confirm results are displayed in the measuring unit inr and the steps to take to change the measuring units back to inr if the meter is displaying the units sec or %q.The meter and test strips were requested for investigation.The meter and strips were returned for investigation.However, the returned strip vial had no remaining test strips available for testing.Therefore, the returned meter was tested with retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.5 inr, qc 2: 5.4 inr and 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.The alleged results of 1.6 inr and 1.3 inr 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.

Event Description

We received a request for assistance setting up a new coaguchek xs system.During that call, there was an allegation of a bleeding event requiring hospitalization for 1 patient when he attempted to use his previous coaguchek xs system on (b)(6) 2022.The coaguchek xs meter was reportedly unavailable for use prior to the bleeding event occurring on (b)(6) 2022.On (b)(6) 2022 the meter memory result was 1.3 inr.The patient¿s warfarin dose was allegedly increased by 5 mg for the week based on this result.When the meter memory was first accessed, the last result prior to the event was 19.7 seconds with a date of (b)(6) 2022.The patient was unsure if he reported the result in seconds as 1.7 inr.The meter was correctly set to inr by the call center agent.Upon re-review of the meter memory, the result on (b)(6) 2022 was 1.6 inr.The patient¿s warfarin dose was allegedly increased based on this result.The patient was reportedly using test strip lot 57260823 with an expiration date of 31-may-2023.On (b)(6) 2022 the patient called for assistance with the meter due to power concerns.On this call, the patient stated he allegedly was unable to get a result from the meter and went to the doctor¿s office for testing on (b)(6) 2022.The patient was tested with the doctor¿s coaguchek xs plus system and the result was reportedly 1.9 inr.There was no allegation the doctor's coaguchek xs plus meter caused or contributed to the bleeding event.The patient¿s warfarin dose was allegedly kept the same for the week: 5 mg monday through friday and 4 mg saturday and sunday.The patient was reportedly advised by the doctor to avoid greens and re-test at home the next week.After troubleshooting steps were performed, the power issue was not resolved.After inserting new batteries, the patient allegedly continued to receive a battery error message and a replacement meter was sent.On (b)(6) 2022 it was reported that the patient was reportedly admitted to the hospital due to blood in his stool on (b)(6) 2022.The patient "had a bleed out" possibly from an ulcer but they were not sure where the blood came from.The patient did not know his inr result at the time of admission to the hospital.The doctors reportedly thought "it was thin" since there was blood in his stool.The patient's warfarin was allegedly stopped at the time of admission.The patient was reportedly treated with one unit of blood.Reportedly, no scoping was performed as the bleeding had stopped after they held the patient¿s warfarin.The patient allegedly did not know his hematocrit at the time of admission.The patient was reportedly given anti-nausea medication.No other treatment was received for inr.The patient's blood glucose was reportedly tested but he did not know the results.The patient was released from the hospital on (b)(6) 2022.The patient¿s therapeutic range is 1.8 ¿ 2.2 inr with a reported testing frequency of weekly.The patient is currently in stable condition.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 15681793
• MDR Text Key: 302506406
• Report Number: 1823260-2022-03376
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 10/27/2022

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 Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/27/2022
• 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
• Treatment: GLIPIZIDE.; LANAPOST.; LEVOTHYROXINE.; METOPROLOL.; OMEGA FOR EYES.; PRESURVISION.; TORSEMIDE.; WARFARIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 96 YR
• Patient Sex: Male
• Patient Weight: 74 KG