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

Catalog Number 10697306

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which matched the patient's history and a corrected report was issued.The customer also stated that they replaced the measurement cartridge which resolved the issue.There will be an investigation on the uploaded data files.The cause of this event is unknown at this time.

Event Description

The customer reported discrepant total hemoglobin (thb) results for one capillary sample run on a rp 500 blood gas analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens reviewed the data files.There is no specific evidence suggesting that the rp 500 co-oximetry on this system at the time of testing was not performing as intended.There were no sampling errors flagged and the thb slope was stable during the sampling time period.There were no thb slope or drifts errors immediately prior to or after the discordant sample.The aqc results were within the expected ranges and the co-ox optical performance was within specifications.The root-cause for the low thb result compared to repeat analyses is unknown.

• Brand Name: RAPIDPOINT 500 BLOOD GAS ANALYZER
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 7400605
• MDR Text Key: 104894100
• Report Number: 3002637618-2018-00041
• Device Sequence Number: 0
• Product Code: GKR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 82 YR