MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. 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	Therapeutic Response, Increased (2272)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Instrumentation laboratory (il) was unable to conduct a thorough investigation.Multiple requests were made for data, however, the data files were not sent for evaluation.Based on the information provided from the customer the gem premier 4000 was performing to specification and the results provided from the gem premier 4000 were not questioned.The error occurred when the technician did not multiply the results by 0.01 (to obtain the fraction value for cohb and methb) when manually transcribing the results from the ticker tape to their laboratory information system.Based on the information provided, no remedial action is required.
Event or Problem Description
The customer reported that methb and cohb were analyzed on their gem premier 4000.Per local practice, their results were manually transcribed from ticker tape to their laboratory information system to convert to si units.The manual transcription requires that staff multiply the ticker tape results by 0.01 to obtain the fraction value for cohb and methb.However, the operator failed to do this and the patient was believed to have a methb of 80%.Based on their calculation error, the physician inappropriately administered methylene blue to the patient.Per the customer, the patient required "serious intervention" and had an extended hospital length of stay.Per the customer, the gem premier 4000 system operated to specification.The error was due to manual calculation errors when converting from % to si units.

• Brand Name: GEM PREMIER 4000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7328352
• Report Number: 1217183-2018-00001
• Device Sequence Number: 104255
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: No Information
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/09/2018
• 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: Hospitalization