RAPIDPOINT 405 10322347

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-23 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[16461382] Customer reported that they scanned a patient id on the instrument and when it crossed over to rapidcomm it was a different patient id. Customer indicated that they caught the incorrect patient id and corrected the issue and they have not had any other similar issue ever since. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5


[16787036] A review of both the rp405 log files and rapidcomm show the patient id entered in the rp405 system is the same one that was transmitted to rapidcomm. This shows that the patient id entered by the customer is the patient id transmitted. Sample order from rapid comm (b)(6) 2014 04:36 jxxxx baby girl 1 ((b)(6)) (b)(6) 2014 04:39 hxxxx baby boy ((b)(6)) (b)(6) 2014 04:49 hxxxx baby boy ((b)(6)) patients jxxxxx has baby 1 and baby 2 (twins); on (b)(6) 2014 jxxxxx baby 1 ((b)(6)) was tested @ 4:36 am but no jxxxxx baby 2 (patient id not provided). It was not until (b)(6) 4:52 am that jxxxxx baby 2 had a sample run (no data provided). The 3rd sample listed on (b)(6) @ 4:49 is the sample they initially believed should have been jxxxx baby 2 coming over but rapidcomm says it is patient hxxxxx ((b)(6)) and the system log (paz) file shows patient hxxxxx ((b)(6)) for both samples as well. Baby 1 jxxxx (1428400354) and baby hxxxxx ((b)(6)) were tested at about the same time on (b)(6) 2014 ~ 4:39; review of sample logs showed results for baby hxxxxx ((b)(6)) had a big change in sample results(ph and pco2) in <12 minutes. Ph/pco2 typically do not change this amount during a 12 minute span. This leads to further evidence there was a preanalytical sample labeling or scanning issue by the customer. Siemens customer complaint center team who worked with the customer to review the rapidcomm logs indicated that the customer did not want to investigate any further and will be looking at their internal practices with bar code labels. Instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217157-2015-00050
MDR Report Key4724493
Report Source06,07
Date Received2015-04-23
Date of Report2015-03-29
Date of Event2014-11-09
Date Mfgr Received2015-03-29
Date Added to Maude2015-05-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSTEVEN ANDBERG
Manufacturer Street2 EDGEWATER DRIVE
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone7812693655
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
Manufacturer StreetNORTHERN ROAD CHILTON INDUSTRIAL ESTATE
Manufacturer CitySUDBURY CO102XQ
Manufacturer CountryUK
Manufacturer Postal CodeCO10 2XQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPIDPOINT 405
Generic NameRP 405
Product CodeGKR
Date Received2015-04-23
Catalog Number10322347
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-23

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