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

Model Number 2261

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pregnancy (3193)

Event Date 02/08/2020

Event Type  Injury  

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 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
• Type of Device: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell road; bedford, ma
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford, ma
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, ma ; 4080329
• MDR Report Key: 9935381
• MDR Text Key: 194343076
• Report Number: 1217183-2020-00001
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other