MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY GEM PREMIER 4000; CLINICAL CHEMISTRY INSTRUMENT, PRODUCT CODE: CHL

Model Number	2261
Medical Device Problem Codes	Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Instrumentation laboratory clinical assessment of the event: measurement of fetal ph as a diagnostic tool to detect fetal acidosis in labor and consequently to assess intrapartum fetal well-being or compromise was described in the 1960s.A normal ph allows labor to continue, a borderline result needs to be repeated at a defined time interval (e.G.30 minutes), and an abnormal result requires delivery (e.G.Urgent or emergent caesarean section).Assessment of fetal blood ph is generally considered to be the most sensitive indicator of birth asphyxia and an abnormal ph classified as less than 7.2 has been shown to have a higher specificity than a pathologic cardiotocography reading in predicting a low apgar score at 1 minute.Nonetheless, in this complaint while the ph was not below 7.2, the medical team decided to proceed with a caesarean section, which was deemed to be unnecessary following a repeat ph measurement on a second analyzer.However, instrumentation laboratory (il) conducted an investigation that included a review of data files from the customer's gem premier 4000.The sensor slopes and calibration drifts when these samples were analyzed on both instruments were within allowable limit.Data obtained from the back-up revealed a mv sensor shift across multiple sensors and all were offset by the same mv value (-0.03 and -0.05) indicating that the reference trace was shorted causing lower recovery on the sample analyzed in the delivery room.A software mitigation to detect this issue has been developed and will be implemented in the field.
Event or Problem Description
It was reported that ph results between two different gem 4000 analyzers (software version 2.3.0) were inconsistent.The customer received a ph value of 7.32 (arterial sample) from the delivery room instrument at 17:47 and a ph of 7.40 (venous sample) just over a minute later on the instrument in the neonatal intensive care unit.As a result of the first ph measurement, the medical team decided to perform a caesarian section; however, based upon the second, higher results the medical team concluded that the caesarian section performed was unnecessary, no adverse events were reported.
Additional Manufacturer Narrative
Additional investigation outcome: to refine the estimate of the impact of the mv sensor shift on the gem premier 4000 ph, the sensor response from additional potentiometric channels which share the reference channel was used.Based on the sample and calibration millivolt of the ph sensor, this would impact the measured sample ph by -0.04 and is within total allowable error specification.This is consistent with the initial assessment and the expected difference between venous and arterial blood.Based on the above, il has determined that the event was not a system malfunction and no remedial action is indicated.As indicated in the original incident report, the il clinical assessment indicated the caesarean section was unnecessary based on the instrument reported ph value.

• Brand Name: GEM PREMIER 4000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT, PRODUCT CODE: CHL
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 6471281
• Report Number: 1217183-2017-00002
• Device Sequence Number: 332857
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other