MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

Catalog Number 10697306

Device Problem Low Test Results (2458)

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

Event Date 12/24/2023

Event Type  malfunction  

Manufacturer Narrative

The customer has provided instrument files for further investigation.Investigation is underway.The customer stated that they are currently operational.The cause of this event is unknown.

Event Description

Customer alleges several discrepant calcium results on their rp500 instrument compared to retesting of different samples on their lab analyzer and another rp500 instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.A review of the summary log showed several d2 excessive drifts and d3 slope errors for the ca++ sensor occurred on the day of event.The first d2 excessive drift for ca++ sensor happened about 1 hour prior to sample analysis of the first reported sample and after sample analysis of a venous sample.A considerable number of calibration errors led to instability of the ca++ sensor temporarily on the date of event and while the samples in question were measured.This can be an attributing factor in producing the observed discrepant low ca++ results.The rp500 sn was working as intended and following the detection of calibration errors when it disabled the calcium sensor 8 times to retrieve the normal performance.Due to unavailability of time of repeat analyses and other analytes¿ parameters measured by comparative systems (with acceptable ca++ values), further investigation on the root cause analysis of discrepant low ca++ results produced by rp500 sn (b)(6) cannot be conducted at this time and a definitive root-cause is undetermined.The rp500 sn (b)(6) is performing as intended and currently operational at the customer site.Note, ph changes can impact the level of ica++ in blood samples.In the absence of ph values for repeat evaluations, investigation to determine if there was an association between ph variations and the observed discrepancy was not possible.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18436783
• MDR Text Key: 331810416
• Report Number: 3002637618-2024-00107
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1