MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH REACTION RING SEGMENT

Model Number	ATELLICA CH REACTION RING SEGMENT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that discordant falsely low results were obtained on three patient samples.A customer service engineer (cse) was dispatched to the customer's site.After inspecting the analyzer, the cse replaced the sample and reagent impeller, source lamp, sample mixer impeller assembly, and cuvette segment.The cse cleaned the sample probe and the sample drain.Analyzer verification indicates acceptable performance after the service visit.No other issues have been reported by the customer since the service visit.The customer provided the cuvette segment to siemens for further evaluation.On 05-oct-2020, siemens identified that this reaction cuvette is defective, and this was in alignment with the issues identified in urgent medical device recall (umdr) achc 20-05.B.Us and urgent field safety notice (ufsn) achc 20-05.B.Ous.Umdrachc 20-05.B.Us was sent to us customers and ufsn achc 20-05.B.Ous was sent to ous customers in february 2020.The umdr and ufsn advise customers of the potential for falsely depressed or elevated results in a small percentage of the atellica ch reaction cuvette segment "19" and above, due to a cuvette defect allowing water bath to contaminate the cuvette.Customers were provided instructions to determine if they have impacted cuvette positions within a cuvette segment.If cuvette segments are identified on their analyzer(s) customers will be asked to contact siemens customer care center to determine additional actions to be taken prior to processing patient samples.Ufsn achc20-05.C.Ous and ufsn achc20-05.D.Ous was issued march 18, 2020.The follow up ufsn achc20-05.C.Ous provides additional instructions, to a laboratory that utilizes comma "," separators (rather than period ".") to successfully evaluate the data and determine if cuvette segments are acceptable for patient sample testing.Ous customers who received ufsn achc20-05.B.Ous released in february will receive achc20-05.C.Ous with the additional instructions).The follow up ufsn achc20-05.D.Ous provides the additional instructions to a laboratory that utilizes comma "," separators (rather than period ".") to successfully evaluate the data and determine if cuvette segments are acceptable for patient sample testing.In this case the additional instructions are intended for ous customers who have not received the achc20-05.B.Ous.
Event or Problem Description
A discordant, falsely depressed calcium_2 (ca_2) result was obtained on a patient sample on an atellica ch 930 analyzer.A depressed glucose hexokinase 3 (gluh_3) result was obtained on another patient sample and a discordant, falsely depressed albumin (alb) result was obtained on a third patient sample on the same analyzer.The falsely depressed results were not reported to the physician(s).The samples were repeated on the same instrument and the repeat results were higher than the discordant results.The repeat results were reported, as the correct results to the physician (s).There are no known reports of patient intervention or adverse health consequences due to the discordant result.

• Brand Name: ATELLICA CH REACTION RING SEGMENT
• Common Device Name: ATELLICA CH REACTION RING SEGMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 10749375
• Report Number: 2432235-2020-00426
• Device Sequence Number: 3141382
• Product Code: JJE
• UDI-Device Identifier: 00630414596143
• UDI-Public: 00630414596143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATELLICA CH REACTION RING SEGMENT
• Device Catalogue Number: 11099326
• Device Lot Number: N1510619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-01/21/2020-002-C
• Patient Sequence Number: 1