BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY LACTATE DEHYDROGENASE2

    MDR report key: 15240222 · Received August 17, 2022

    Report

    Report Number
    3005094123-2022-00174
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 4, 2022
    Report Date
    November 14, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CFJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY LACTATE DEHYDROGENASE, 2 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. DEVICE HISTORY RECORD REVIEW FOR LOT 39506UD00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY LACTATE DEHYDROGENASE 2 ASSAY FOR LOT 39506UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN SECTION A1 - SID (B)(6), SECTION B5, D4 EXPIRATION DATE, H4 MANUFACTURE DATE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE THE INITIAL CODING IN SECTION H6 FOR COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE2 (LDH2) RESULTS FOR SEVERAL SAMPLES. RESULTS PROVIDED: ON (B)(6)2022 SID: (B)(6) INITIAL RESULT = 259 U/L, REPEAT RESULT 175 U/L. ON (B)(6)2022 SID: (B)(6) INITIAL RESULT = 341 U/L, REPEAT RESULTS = 179 U/L, 182 U/L, 179 U/L. ON (B)(6)2022 SID: (B)(6) INITIAL RESULT 263 U/L, REPEAT RESULTS = 172 U/L, 178 U/L. ON (B)(6)2022 SID: (B)(6) RESULTS: INITIAL RESULT = 223 U/L, REPEAT RESULTS = 214 U/L, 228 U/L, 219. U/L, 225 U/L, 232 U/L, 229 U/L, 247 U/L, 230 U/L, 254 U/L, 216 U/L, 240 U/L, 252 U/L, 259 U/L. (CUSTOMER PROVIDED NORMAL RANGE 125 - 220 U/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE2 (LDH2) RESULTS FOR SEVERAL SAMPLES. RESULTS PROVIDED: 04AUG2022 SID: (B)(6). INITIAL RESULT = 259 U/L, REPEAT RESULT 175 U/L. 05AUG2022 SID: (B)(6). INITIAL RESULT = 341 U/L, REPEAT RESULTS = 179 U/L, 182 U/L, 179 U/L. 04AUG2022 SID: (B)(6). INITIAL RESULT 263 U/L, REPEAT RESULTS = 172 U/L, 178 U/L. 05AUG2022 SID: (B)(6). RESULTS: INITIAL RESULT = 223 U/L, REPEAT RESULTS = 214 U/L, 228 U/L, 219 U/L, 225 U/L, 232 U/L, 229 U/L, 247 U/L, 230 U/L, 254 U/L, 216 U/L, 240 U/L, 252 U/L, 259 U/L. (CUSTOMER PROVIDED NORMAL RANGE 125 - 220 U/L). ADDITIONAL INFORMATION PROVIDED ON 25AUG2022. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: 24AUG2022 SID: (B)(6). MALE PATIENT INITIAL RESULT = 624 U/L, REPEAT RESULTS = 173 U/L, 164 U/L 25AUG2022 SID: (B)(6). LDH FEMALE PATIENT INITIAL RESULT = 313 U/L, REPEAT RESULTS = 228 U/L, 260 U/L, 222 U/L, 225 U/L, 226 U/L, 220 U/L, 222 U/L, 221 U/L, 222 U/L, 221 U/L, 220 U/L, 215 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED ON 25AUG2022. THE CUSTOMER PROVIDED THE ADDITIONAL RESULTS: (B)(6) 2022 SID (B)(6) MALE PATIENT INITIAL RESULT = 624 U/L, REPEAT RESULTS = 173 U/L, 164 U/L (B)(6) 2022 SIDS (B)(6) FEMALE PATIENT INITIAL RESULT = 313 U/L, REPEAT RESULTS = 228 U/L, 260 U/L, 222 U/L, 225 U/L, 226 U/L, 220 U/L, 222 U/L, 221 U/L, 222 U/L, 221 U/L, 220 U/L, 215 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288688 ALINITY LACTATE DEHYDROGENASE2 NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE CFJ A.I.D.D LONGFORD 39506UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, (B)(6) | ALNTY C PROCESSING MODU, 03R67-01, (B)(6) | ALNTY C PROCESSING MODU, 03R67-01, (B)(6)