MAUDE MDR 9541916

MDR report key: 9541916
Report number: 2939693-2020-00002
Event key: 0
Event type: 3
Date of event: 2019-12-03
Date received: 2020-01-02
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MS. RONI THEBO
Address: 3240 WHIPPLE RD UNION CITY CA 94587 US
Phone: 269-269-2693
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	PICCOLO XPRESS CHEMISTRY ANALYZER	PICCOLO ANALYZER	ABAXIS, INC.	JJG	1100-0000	1100-0000					Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-01-02	0

Event Narratives#

N

Patient 1

ON (B)(6) 2019, ABAXIS RECEIVED A CALL FROM A CUSTOMER CONCERNING THEIR LOANER PICCOLO XPRESS ANALYZER (SERIAL NUMBER: (B)(4)) REPORTING INCORRECT REFERENCE RANGE VALUES ON PATIENT SAMPLES RAN ON (B)(6) 2019. THE LOANER ANALYZER HAD THE NEWEST VERSION OF SOFTWARE 3.1.35/2.1.55. DURING A PRELIMINARY INVESTIGATION OF THE ISSUE, ABAXIS CONFIRMED A TOTAL RECEIPT OF 5 CUSTOMER COMPLAINTS (DATE OF CALLS RANGE FROM (B)(6) 2019); FROM FOUR CUSTOMER SITES REGARDING THE SAME/SIMILAR ISSUE. FURTHER INVESTIGATION INTO THE COMPLAINT REPORTS, ABAXIS CONFIRMED A SOFTWARE FAILURE IN THE NEWLY RELEASED PICCOLO XPRESS SOFTWARE VERSION 3.1.35/2.1.55 WHICH MAY CAUSE THE PRODUCT TO DISPLAY INCORRECT REFERENCE RANGES FOR CERTAIN ANALYTES WHEN GENDER SELECTION IS NOT SET ON THE DEVICE. THE ISSUE IS LIMITED TO THE NEWLY RELEASED SOFTWARE VERSION 3.1.35/2.1.55 WHICH HAS ONLY BEEN INSTALLED ON LOANERS AND REPAIRED UNITS AND NOT ON ANY NEW BUILDS. ABAXIS HAS STOPPED LOADING NEW SOFTWARE ON LOANERS/REPAIRED UNITS SINCE RECEIVING CALLS REGARDING THE ISSUE. ON (B)(6) 2019, ABAXIS INITIATED A FILED ACTION TO NOTIFY ALL CUSTOMERS WHO HAVE RECEIVED IMPACTED LOANER/REPAIRED ANALYZERS WITH THE NEWEST SOFTWARE VERSION 3.1.35/2.1.55 (FDA CORRECTION/REMOVAL NUMBER: 2939693-12/16/2019-001-R). NO IMPACT TO PATIENTS HAS BEEN REPORTED BY CUSTOMERS FROM THE ISSUE. ADDITIONAL INVESTIGATION REGARDING THE ISSUE IS UNDERWAY. SINCE 5 INDIVIDUAL CALLS FOR 5 INSTRUMENT SERIAL NUMBERS HAVE BEEN RECEIVED FOR THIS ISSUE, 5 INDIVIDUAL MDR SUBMISSIONS FOR EACH INSTRUMENT SERIAL NUMBER WILL BE SUBMITTED (MDR 2939693-2020-00001, MDR 2939693-2020-00003, MDR 2939693-2020-00004, MDR 2939693-2020-00005).

D

Patient 1

INCORRECT REFERENCE RANGES FOR SOME ANALYTES.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
EABA11001511	Piccolo Xpress Military Deployment Kit	ABAXIS, INC.	JJG	2017-06-30
EABA110000001	Piccolo Xpress	ABAXIS, INC.	JJG	2016-09-23

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K972409	JJG	AG CHEMISTRY ANALYZER SYSTEM	Landmark Scientific, Inc.	1997-08-28
510(k)	K942782	JJG	PICCOLO(TM)	Abaxis, Inc.	1995-03-13
510(k)	K934592	JJG	EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR	Abaxis, Inc.	1994-04-06
510(k)	K920942	JJG	OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER	Olympus Corp.	1992-06-10
510(k)	K910222	JJG	COBAS ALPHA	Roche Diagnostic Systems, Inc.	1991-02-27

MAUDE MDR 9541916

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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