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); High Test Results (2457)

Patient Problems Transient Ischemic Attack (2109); Speech Disorder (4415); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2021

Event Type  Injury  

Manufacturer Narrative

The medical assessment concluded, the elevated meter result of 2.3 inr may be impacted due to the patient being under antibiotics (ciprofloxacini) due to diagnosed infection in urine and blood at his previous hospitalization on (b)(6) 2021.The duration of antibiotics administered is not defined.Common clinical practices follow a treatment with antibiotics for hospitalized patients of 10-14 days, depending on bacterial identification and underlying co.Morbids (in this case diabetes mellitus type 2 is assumed based on the medication with metformin).A potential impact of the administered antibiotics (ciprofloxacin) on the performance of the meter cannot be completely excluded.Therefore the contribution of the device to the tia event on (b)(6) 2021 cannot clearly be assessed.Per product labeling, in the "limitations of procedure information for you and your physician" section, the following is stated: "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted.(b)(6).The patient¿s meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.2 - 3.4 inr): qc 1: 2.7 inr qc 2: 2.7 inr qc 3: 2.7 inr the obtained results were in the allowed range.No error messages occurred during the investigation.Test strip retention samples passed the internal inspection.The customer's alleged result of 1.6 inr at 12:00 pm on (b)(6) 2021 was observed in the patient's meter memory as 2.3 inr on (b)(6) 2021 at 12:14 pm.All other results alleged by the customer were observed in the meter¿s patient result memory.The investigation did not identify a product problem.The cause of the event could not be determined.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." unique identifier (udi) #: (b)(4).

Event Description

We have received an allegation of a tia event while using the coaguchek xs meter serial number (b)(4).On (b)(6) 2021, the patient went to the hospital and was diagnosed with a bacterial infection in his urine and blood.The result from the patient¿s meter was 1.6 inr, confirmed in the meter memory.The initial reporter could not provide whether the patient was tested for inr upon arriving at the hospital as she was not allowed in with the patient.The patient was admitted to the hospital and treated with antibiotics.The customer was also placed on a heparin drip and transitioned off of it when he was discharged from the hospital on (b)(6) 2021.On (b)(6) 2021, the reporter stated that the customer could not speak so she drove the customer to the hospital.The initial reporter stated the result from the meter at approximately 12:00 p.M.Was 1.6 inr and the result from the hospital laboratory at approximately 3:00 p.M.Was 1.3 inr.The laboratory method is unknown.The result in the meter memory on (b)(6) 2021 at 12:14 p.M.Was 2.3 inr which does not match the alleged result of 1.6 inr.The initial reporter stated the meter is set to the correct date.The patient was admitted to the hospital and was treated with coumadin.A ct scan was performed and showed no bleeding of the brain.The patient was diagnosed with a tia.The patient was discharged from the hospital on (b)(6) 2021 and is stable.The customer¿s therapeutic range is 1.7-2.2 inr.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Question: you concluded that "the elevated meter result of 2.3 inr may be impacted due to the patient being under antibiotics (ciprofloxacin)".Do you have any interference study data on ciprofloxacin (and/or other antibiotics)? answer: the coagucheck xs package insert acknowledges the potential interaction of antibiotics with oral anticoagulants.Our internal testing, using fda recognized industry standards clsi ep07 and ep37, shows that there is no direct influence of ciprofloxacin on the performance of the coaguchek system.There is also external information to show that ciprofloxacin and other antibiotics may enhance the effects of warfarin.Here are three examples: association between the prothrombin time-international normalized ratio and concomitant use of antibiotics in warfarin users: focus on type of antibiotic and susceptibility of bacteroides fragilis to antibiotics.Yagi t, naito t, kato a, hirao k, kawakami j.Ann pharmacother.2021 feb;55(2):157-164.Doi: 10.1177/1060028020940728.Epub 2020 jul 7.Pmid: 32633584.Background: the difference in type of antibiotics and susceptibility of bacteroides fragilis to antibiotics may influence warfarin anticoagulation.Source: https://pubmed.Ncbi.Nlm.Nih.Gov/32633584/ comparative study am j geriatr pharmacother 2012 dec;10(6):352-60.Doi: 10.1016/j.Amjopharm.2012.09.006.Epub 2012 oct 22.Warfarin-antibiotic interactions in older adults of an outpatient anticoagulation clinic parinaz k ghaswalla 1, spencer e harpe, daniel tassone, patricia w slattum pmid: 23089199 doi: 10.1016/j.Amjopharm.2012.09.006 results: a total of 205 patients had 364 prescriptions for warfarin and antibiotics concomitantly, and there was a significant interaction between antibiotic and time (f(15, 358) = 1.9; p = 0.0221).Antibiotics with a significant increase in inr were amoxicillin (p = 0.0019), azithromycin (p < 0.0001), ciprofloxacin (p = 0.002), levofloxacin (p < 0.0001) and moxifloxacin (p < 0.0001).There was a significant association between type of antibiotic and secondary outcomes of overanticoagulation.Systematic overview of warfarin and its drug and food interactions anne m.Holbrook, md, pharmd, msc, frcpc; jennifer a.Pereira, msc; renee labiris, phd; et alheather mcdonald, msc; james d.Douketis, md, frcpc; mark crowther, md, msc, frcpc; philip s.Wells, md, frcpc author affiliations article information.Arch intern med.2005;165(10):1095-1106.Doi:10.1001/archinte.165.10.1095.In addition to these studies, many versions of ciprofloxacin labeling contain information regarding its effects on warfarin and provide information to monitor prothrombin time and inr when using ciprofloxacin with an oral anticoagulation.

• 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: 11497601
• MDR Text Key: 241906790
• Report Number: 1823260-2021-00816
• 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: 04/30/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49017421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 02/15/2021
• Supplement Dates FDA Received: 04/05/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; BUMETANIDE; CARVEDILOL; CIPROFLOXACIN; FEBUXOSTAT; FERROUS SULFATE; LATANOPROST; LOSARTAN; MAGNESIUM OXIDE; METFORMIN; PRANDIN; PROTONIX; VITAMIN B 12; VYTORIN; WARFARIN; ZOLOFT; ZYRTEC
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 60