BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052036 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04184
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK COMPARISON TO A LAB RESULTS OF 113MG/DL ON THE METER, AND 446MG/DL AT THE LAB WHILE USING THE INFORM SYSTEM. CALLER REPORTS PATIENT RECEIVED NO TREATMENT BASED ON METER READING. CALLER REPORTS QUALITY CONTROLS HAVE BEEN PASSING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT, AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550512

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LEVAQUIN 500MG TABLE| PREVACID 30MG CAPSUL| AEROCHAMBER| IBUPROIFEN CHILDREN| HYDROMORPHONE 1MG/ML| HYDROCODONE/APAP 10/| HALOPERIDOL LAC 2MG/| PROTONIX 40 MG TAB| ONDANSETRON 2MG/ML 2| PRILOSEC 20MG| NEOSTIGMINE 1:1000 V| NARCAN 0.4MG/ML AMPU| FLORICAL CAPSULE| MUPIROCIN 2% OINTMEN| THERAPEUTIC VIT/MIN| FLUCONAZOLE 200MG TA| FERROUS SULFATE 325M| LOVENOX 30MG PREFILL| COLACE 100MG CAP| D5-1/2NS/KCL 20MEQ/L| DEXTROSE 5%-1/2NS IV| ROCEPHIN 1GM/50 ML P| CEFAZOLIN 1GM/D5W BA| WELLBUTRIN 100MG TAB| IPRATROPIUM BROMIDE| ISOVUE-300 61% 100ML| NOVOLIN R VIAL 1UNI| CYANOCOBALAMIN 1000M| GLYCOPYRROLATE 0.2MG| FUROSEMIDE 40MG/4ML| MIDAZOLAM 2MG/2ML VI| LIPITOR 10MG TABLET| ATENOLOL 25MG TABLET| ASPIRIN 81MG TABLET| VITAMIN C 500MG TABL| EFFEXOR XR 75MG CAPS| IV VANCOMYCIN 1GM VI| SUCCINYLCHOLINE 200M| SENNA TABLET| SENNA SOD TABLET 8.6| BETHAPRIM DS TABLET| ROCURONIUM 50MG/5 ML| REMOVE PATCH/CREAM/O| SEROQUEL 25MG TAB| PROPRANOLOL 40MG TAB| PROPOFOL 1000MG/100M| KLOR-CON 20MEQ PACKE| PNEUMOVAX 23 SDV| PAROXETINE 20MG TABL| PROTONIX IV 40MG| DONNATAL ELIXIR 5ML| FLUOXETINE 20MG CAPS| PULMICORT TURBUHALER| ACETAMINOPHEN 325MG| ALBUTEROL| ZOLPIDEM 5MG TABLET| MYLANTA/MAALOX PLUS| ALAMAG SUSPENSION| CITRATE OF MAGNESIA| TOPROL XL 25MG ER| METOCLOPRAMIDE 10MG/| MEPERIDINE 50MG/ML T| MAGNESIUM SULFATE 2G| MILK OF MAGNESIA SUS| ZYVOX 600MG TABLET| LIDOCAINE 2% VISCOUS| BACITRACIN STER POWD| GRANULEX SPRAY| PREDNISONE 20MG TABL| PRAVASTATIN 10MG TAB| POLYETHYLNE CLYCOL 2| TEMAZEPAM 15MG CAPSU| SINGULAIR 10 MG| AMITIZA 24 MCG| HEMOCYTE PLUS TABULE| INSULIN HUMALOG 100U| ATROPINE 0.4MG/ML VI| FAMOTIDINE 20MG/2ML| SODIUM CHLORIDE 0.9%| LIDODERM PATCH 5%| AZITHROMYCIN 250MG T| XYLOCAINE SPRAY (OR)| BISACODYL 5MG TABLET| NEBCIN 1.2GM VIAL| NITROFURANTOIN MCR 5| HALOPERIDOL 1MG TABL| POLYMYXIN B 500| TRILAFON 5MG/ML AMPU| ACETYLCYSTEINE 10% V| MORPHINE 4MG/ML CARP| PROTONIX 20MG| DEXTROSE 5%/WATER IV| BUPIVACAINE/EPI 0.25| GOLYTTELY SOLUTION| CEFAZOLIN 1GM VIAL| LIDOCAINE HCL 1% VIA| KETOROLAC 30MG/ML VI| FENTANYL 250MCG/5ML| NEXIUM 40MG CAPSULE| FOLIC ACID 1MG TABLE| TOPAMAX 25MG TAB| BENZONATATE 1000MG CA| SOLU-MEDROL 40MG VIA| MUCINEX SA 600MG TAB| NITRO-BID 2% OINTMEN| COUMADIN TECHING PA| BENZTROPINE MES 0.5M| LORAZEPAM 0.5MG TABL| COMADIN 2.5MG TABLE| FLUARIX PREFILLED SY| ALBUTEROL| HYDROMET SYRUP| PHENERGAN 25MG/ML AM| SIMETHICONE DROPS (O| BENADRYL 50MG/ML VIA