FDA.reportPublic FDA data

MAUDE MDR 1670681

MDR report key
1670681
Report number
1823260-2010-02582
Event key
0
Event type
3
Date of event
2010-04-14
Date received
2010-04-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA ERIC KOLODZIEJ
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COBAS 6000 C501 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJFMNA05036453001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-300

Event Narratives#

D

Patient 1

THE USER STATED TOTAL BILIRUBIN RESULTS WERE ERRONEOUSLY HIGH AND WERE REPORTED. SHE STATED SHE HAD ACCIDENTALLY DELETED ALL OF HER CALIBRATORS ON THE SYSTEM AND THEN REINSTALLED THEM BY DOWNLOADING THEM. WHEN THEY RAN PATIENT SAMPLES, THEY HAD 36 BILIRUBIN RESULTS THAT HAD TO BE CORRECTED BECAUSE "IT SEEMED LIKE THE DECIMAL PLACE WAS OFF ON THE SYSTEM". THE USER RECALIBRATED THE ASSAY, RAN QC AND RESULTS WERE ACCEPTABLE. NO PATIENTS WERE AFFECTED AS THE RESULTS WERE CORRECTED DURING THE NEXT SHIFT. THE BILIRUBIN REAGENT LOT NUMBER WAS 15830300. SAMPLES ARE LISTED AS INITIAL RESULT FOLLOWED BY REPEAT RESULT FOR ANOTHER C501 ANALYZER. ALL RESULTS ARE IN MG/DL. THE FOLLOWING SAMPLE WERE REPEATED ON (B)(6) 2010. SAMPLE 1: ((B)(6) FEMALE) 5.9, 0.6. SAMPLE 2: ((B)(6) MALE) 29.7, 2.8. SAMPLE 3: ((B)(6), FEMALE) 3.2, 0.2. SAMPLE 4: ((B)(6), MALE) 5.0, 0.4. SAMPLE 5: ((B)(6), FEMALE) 2.5, 0.2. SAMPLE 6: ((B)(6), FEMALE) 2.8, 0.3. SAMPLE 7: ((B)(6), FEMALE) 5.5, 0.5. SAMPLE 8: ((B)(6), FEMALE) 11.7, 1.1. SAMPLE 9: ((B)(6), FEMALE) 1.4, 0.1. SAMPLE 10: ((B)(6), MALE) 2.9, 0.3. SAMPLE 11: ((B)(6), MALE) 5.0, 0.4. SAMPLE 12: ((B)(6), FEMALE) 1.6, 0.1. THE FOLLOWING SAMPLE WERE REPEATED ON (B)(6) 2010. SAMPLE 13: ((B)(6), FEMALE) 2.8, 0.2. SAMPLE 14: ((B)(6), FEMALE) 3.5, 0.3. SAMPLE 15: ((B)(6), FEMALE) 4.6, 0.4. SAMPLE 16: ((B)(6), FEMALE) 4.5, 0.4. SAMPLE 17: ((B)(6), FEMALE) 4.2, 0.3. SAMPLE 18: ((B)(6), FEMALE) 4.5, 0.4. SAMPLE 19: ((B)(6), MALE) 4.8, 0.4. SAMPLE 20: ((B)(6), FEMALE) 4.4, 0.4. SAMPLE 21: ((B)(6), FEMALE) 2.1, 0.1. SAMPLE 22: ((B)(6), MALE) 5.2, 0.5. SAMPLE 23: ((B)(6), FEMALE) 3.3, 0.3. SAMPLE 24: ((B)(6), FEMALE) 3.6, 0.3. SAMPLE 25: ((B)(6), FEMALE) 3.9, 0.3. SAMPLE 26: ((B)(6), MALE) 2.7, 0.2. SAMPLE 27: ((B)(6), MALE) 3.5, 0.3. SAMPLE 28: ((B)(6), MALE) 4.6, 0.4. SAMPLE 29: ((B)(6), MALE) 4.0, 0.3. SAMPLE 30: ((B)(6), MALE) 6.4, 0.5. SAMPLE 31: ((B)(6), MALE) 4.8, 0.3. SAMPLE 32: ((B)(6), FEMALE) 5.2, 0.4. SAMPLE 33: ((B)(6), FEMALE) 5.9, 0.5. SAMPLE 34: ((B)(6), MALE) 6.4, 0.5. SAMPLE 35: ((B)(6), MALE) 4.6, 0.4. SAMPLE 36: ((B)(6), MALE) 11.6, 1.1.

N

Patient 1

.

D

Patient 1

ACCORDING TO THE REPORTER: THE FIRST SULU WAS FIRED ACROSS STOMACH TO CREATE A GASTRIC POUCH. SOME OF THE STAPLES DID NOT FORM PROPERLY. THE 2ND SULU WAS FIRED BEHIND THE FIRST SULU AND THE SAME CONDITION OCCURRED WITH SOME OF THE STAPLES NOT PROPERLY FORMED. A 3RD SULU WAS FIRED SUCCESSFULLY BEHIND 2ND STAPLE LINE. GREEN RELOADS WERE USED SUCCESSFULLY FOR THE REMAINDER OF GASTRIC POUCH FORMATION. THE FIRST AND SECOND STAPLE LINES WERE EXCISED AND TISSUE WAS KEPT BY THE SURGEON.

N

Patient 1

THE FIELD APPLICATION SPECIALIST DETERMINED THE USER ACCIDENTALLY DELETED ALL CALIBRATORS ON THE SYSTEM AND RELOADED/ADDED THE CALIBRATORS BACK ON. THE TOTAL BILIRUBIN ASSAY REQUIRED A PACK CALIBRATION AND A LOT CALIBRATION AFTER THE CHANGES. SAMPLES WERE RUN BEFORE CALIBRATIONS WERE DONE. THE USER PERFORMED THE NECESSARY CALIBRATIONS WHICH WERE ACCEPTABLE. QC RECOVERED WITHIN ACCOUNT'S ACCEPTABLE RANGES.