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

Catalog Number 10697306

Device Problem High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens is in process of investigating this event.The cause for the event is unknown at this moment.

Event Description

Customer had opinion that the rp 500 measures nbilli higher than the radiometer and another photometer.Customer indicated that the photometer and the radiometer would correlate fine.There was no report of serious injury due to this event.

Manufacturer Narrative

Outcomes attributed to adverse event: death was checked off as an error.There was no report of injury due to this event.

Manufacturer Narrative

Siemens current product support (cps) team investigated customer returned data.For one particular patient which printouts of the rp500 and the abl835 results were provided, the customer noted that the nbili result was '<2.0' on the rp500 but '16.6' on the abl835.In actuality, this sample was flagged on the rp500 as questionable results (with ? marks) for thb, the co-ox fractions, and nbili.Based on the flagging message, the customer should not have acted on these results.There is indication that some of the specimens may have varying degrees of hemolysis, based on elevated k+ results.A robust side-by-side method comparison of nbili between the rp500 and the abl835 (or the lab chemistry system) would have to be conducted at the hospital site on at least 40 paired patient specimens in order to understand the true relationship between the two systems.Similar studies of comparable siemens blood gas systems have not shown the trend indicated by this customer (on very limited dataset).If a method correlation is established, the use of an appropriate set of correlation coefficients values can be utilized so that the rp500 nbili assay results more closely matches the comparative device (be it the abl or any chemistry analyzer model, for instance).This correlation coefficient feature is offered in system set-up.Evidence available indicates that the rp500 co-oximeter (which dictates thb, fractions and nbili performance) was functioning correctly.There is no evidence that the rp500 nbili is not performance to expectations.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 5142330
• MDR Text Key: 28156206
• Report Number: 1217157-2015-00145
• Device Sequence Number: 1
• Product Code: KHP
• 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: Physicist
• Type of Report: Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10697306
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1