MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY COMPANY GEM PREMIER 4000; CLINICAL CHEMISTRY INSTRUMENT

Model Number	2261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pregnancy (3193)
Date of Event	02/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Instrumentation laboratory conducted an investigation that included a review of data files from the customer's gem premier 4000 blood gas analyzer.Investigation of sample data did not identify any failures with the ph sensor; however, the sensor file showed a ph recovery of 7.17, not 7.11 as indicated by the customer.Per the clinical assessment done by instrumentation laboratory for a ph < 7.2, the physician's decision to proceed with an urgent caesarian section is consistent with current recommendations.The investigation confirmed that there was no product malfunction and therefore no remedial action is indicated.
Event or Problem Description
The manufacturer received a complaint indicating questionable fetal scalp ph results after a ph result of 7.11 was displayed on a gem premier 4000 system.However, the result could not be retrieved in the instrument after an error message was displayed ("air detected within sample.Displayed results questionable").Based upon the displayed result, the physician was notified, and the decision was made to proceed with an urgent caesarian section.

• Brand Name: GEM PREMIER 4000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford, ma
• MDR Report Key: 9935381
• Report Number: 1217183-2020-00001
• Device Sequence Number: 16332461
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/08/2020
• 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