MAUDE Adverse Event Report: OSWEGO HOSPITAL ATELLICA CH 930 ACETAMINOPHEN (ACET); COLORIMETRY, ACETAMINOPHEN

Catalog Number 11097522

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted the siemens customer care center (cc) to report an observation of a falsely depressed acetaminophen (acet) result.Controls (qcs) recovered out of ranges on the day of the event.Siemens remotely reviewed the instrument data and found the customer entered the wrong value for the toxicology calibrator.The provided calibrator definition value of 9.2 mg/dl should have been added as 92 g/ml, as the customer reports in g/ml.The interpretation of results of the instructions for use states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." siemens is investigating.Based on the available, a product performance issue has not been identified.

Event Description

A falsely depressed acetaminophen (acet) result was obtained on a patient sample on a atellica ch 930 analyzer.The erroneous result was reported to the physician(s) and was not questioned.The sample was repeated on an alternate atellica ch 930 analyzer.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).The patient had a known high value earlier in the day.This was a timed follow up collection and the customer was expecting an elevated result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed acet result.

Manufacturer Narrative

Siemens filed mdr 2432235-2023-00202 initial report on 2023-07-04.Additional information: 2023-07-06.Siemens closed the investigation for a united states (us) customer observation of a falsely depressed atellica ch acetaminophen (acet) result.After reviewing the information provided, siemens determined that the customer began using a new lot of atellica ch toxicology calibrator (tox cal) on (b)(6) 2023.The customer incorrectly entered the calibrator value definition for acet.The provided value of 9.2 mg/dl on the tox cal definition card should have been entered as 92 g/ml, since the customer uses g/ml reporting units.Lot calibration was performed on well 2 of the reagent pack on-board on (b)(6) 2023 using the incorrect tox cal value and then subsequent pack c0 adjusts followed.The customer does not perform qc with calibration.No qc had been run on well 2 until on (b)(6) 2023, during troubleshooting of the discordant result.The correct tox cal definition value of 92 g/ml was entered onto the instrument and a fresh reagent pack was used to recalibrate the lot.Calibration and qc were all within range.Based on additional information, section d8 was updated from "unknown" (listed in the initial mdr report filed 2023-07-04) to "no"(in this supplemental report).Based on the investigation results, section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH 930 ACETAMINOPHEN (ACET)
• Type of Device: COLORIMETRY, ACETAMINOPHEN
• Manufacturer (Section D): OSWEGO HOSPITAL; 110 w sixth st; oswego NY 13126
• Manufacturer (Section G): SIEMENS - NEWARK_SEKISUI DIAGNOSTICS P.E.I. INC.; 70 watts avenue; registration # 8020316; charlottetown, pe c1e 2b9 ; CA
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17253165
• MDR Text Key: 318358384
• Report Number: 2432235-2023-00202
• Device Sequence Number: 1
• Product Code: LDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Catalogue Number: 11097522
• Device Lot Number: 123496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female