FDA.reportPublic FDA data

MAUDE MDR 5427195

MDR report key
5427195
Report number
1823260-2016-00132
Event key
0
Event type
3
Date of event
2016-01-04
Date received
2016-02-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
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
0COBAS 8000 E602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSNALNA05990378001NAR *
1COBAS 8000 E602 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJENA05990378001NAR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-1001. O

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

D

Patient 1

A FEMALE OF UNKNOWN REPRODUCTIVE AGE WAS INITIALLY FOUND TO HAVE AN ELEVATED INTACT HUMAN CHORIONIC GONADOTROPIN + THE SUBUNIT (HCGB) RESULT OF 822 IU/L, WHICH COULD INDICATE THE PATIENT WAS APPROXIMATELY 4-5 WEEKS PREGNANT. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND A SURGICAL ABORTION WAS PERFORMED ON THE PATIENT AS THE PATIENT STATED THEY "DID NOT WISH FOR A PREGNANCY". THE PATIENT WAS STATED TO BE IN A CENTER FOR REFUGEES IN (B)(6). PHYSICIANS AT THE LOCATION REPORTED TO THE FACILITY THAT THE HCGB TEST WAS GIVING IMPLAUSIBLE RESULTS. BASED ON THESE REPORTS, THE PATIENT SAMPLE WAS LATER REPEATED. SUBSEQUENT REPEAT TESTING OF THE PATIENT SAMPLE REVEALED A RESULT OF 0.311 IU/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2016. THE ANALYZER AUTOMATICALLY REPEATED THE SAMPLE ON (B)(6) 2016, RESULTING WITH A FINAL VALUE OF 0.320 IU/L. THE SAMPLE WAS ALSO REPEATED AT ANOTHER SITE ON AN E602 ANALYZER, RESULTING AS 0.247 IU/L. WHILE THE PATIENT STATED THE PATIENT DID NOT WISH FOR A PREGNANCY, IT HAS NOT BEEN CONFIRMED IF THE PATIENT WAS ACTUALLY PREGNANT AT THE TIME OF THE EVENT. CLARIFICATION HAS BEEN REQUESTED. LIMITED RECORDS DO NOT SHOW IF ANOTHER TEMPORALLY SEPARATED HCGB VALUE WAS AVAILABLE. NO RECORD OF AN ULTRASOUND WAS AVAILABLE. IT IS UNCLEAR IF ANY ADDITIONAL TESTING WAS DONE TO CONFIRM PREGNANCY PRIOR TO THE PROCEDURE. THE PATIENT'S CURRENT CONDITION AND OTHER MEDICAL HISTORY HAVE BEEN REQUESTED BUT NOT PROVIDED. TYPICALLY, A CONFIRMATORY ULTRASOUND IS PERFORMED OR THE HCGB IS REPEATED ON THE PATIENT IN ORDER TO DEMONSTRATE A VIABLE, GROWING FETUS PRIOR TO PERFORMING A SURGICAL ABORTION. DUE TO THE LIMITED RECORDS AVAILABLE, IT IS UNCLEAR IF THIS WAS DONE. IF AN ULTRASOUND OR A FOLLOW UP HCGB WAS NOT DONE PRIOR TO THE PROCEDURE, THIS REPRESENTS A DEPARTURE FROM THE COMMUNITY STANDARD OF CARE. AN ELEVATED HCGB MAY ALSO BE SEEN AFTER A RECENT SPONTANEOUSLY ABORTED FETUS AND THE HCG LEVEL IS DECREASING TO NON-PREGNANT LEVELS. THE HCGB REAGENT LOT NUMBER WAS 18742800. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE BEAD MIXER ADJUSTMENTS AND THESE WERE OK. HE FOUND THAT THE BEAD MIXER WAS DIRTY AND HE CLEANED IT. HE CLEANED THE REAGENT PIPETTOR AND FOUND THE ADJUSTMENTS TO BE ACCEPTABLE. HE FOUND A LOT OF CRYSTALLIZATION AT THE TIP OF THE SAMPLE PROBE AND HE CLEANED THE PROBE. HE FOUND THE LIQUID LEVEL DETECTION OF THE PROBE TO BE TOO LOW, SO HE ADJUSTED IT. HE CLEANED AND ADJUSTED ALL SIPPER PROBES. HE RAN PERFORMANCE TESTING.

N

Patient 1

IT HAS BEEN CLARIFIED THAT THE INVOLVED PATIENT WAS NOT ADVERSELY AFFECTED. THE PATIENT RECEIVED THE INITIAL RESULTS ON (B)(6) 2016 AND WENT TO THE ABORTION CLINIC. THE ABORTION CLINIC THEN ADVISED THE PATIENT TO WAIT FOR ONE WEEK BEFORE STARTING AN ABORTION PROCEDURE AND THE PATIENT DID WAIT. ON (B)(6) 2016, THE TREATING PHYSICIAN WAS INFORMED THAT THE INITIAL RESULTS WERE NOT CORRECT. THE PATIENT WAS THEN DIRECTLY INFORMED THAT SHE WAS NOT PREGNANT AND AN ABORTION PROCEDURE WAS NOT INITIATED.

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. OBSERVED CONTAMINATION ON THE MIXER COULD CAUSE A CONTAMINATION OR BLOCKAGE OF THE ANALYZER FLUIDICS. THE ORIGIN OF THE CONTAMINATION COULD NOT BE DETERMINED.

N

Patient 1

THE FIELD SERVICE REPRESENTATIVE REPLACED SEALS AND THE MIXER ON THE ANALYZER.

N

Patient 1

THE FIELD SERVICE ENGINEER RAN PERFORMANCE TESTING AND THIS FAILED. HE ADJUSTED THE PHOTOMULTIPLIER TUBE VOLTAGE AND THEN SUCCESSFULLY RAN A BLANK CELL CALIBRATION. AFTER THIS, CALIBRATIONS AND CONTROLS WERE OKAY.