MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-01 for CALCIUM GEN. 2 05061482190 manufactured by Roche Diagnostics.
[3899229]
The customer received questionable results for calcium (ca) on two patient samples. Of those two, it was determined that one patient had erroneous results that were reported outside of the laboratory. The customer stated that they received the two low ca results and then repeated the samples on another analyzer. The customer then placed a sample back on the initial instrument to repeat it when an instrument error alarm occurred. The customer checked the probes and noted that there were three reagent transfer probes that were bent. The customer noted that this was the second occurrence of bent probes that day. The customer indicated that the splashguards were knocked off and that all cassettes were in place. The initial ca result was 1. 7 mg/dl, which was reported outside of the laboratory. The sample was repeated on another instrument and generated a result of 7. 9 mg/dl. The customer deemed the repeat result to be the correct result and called and corrected the result. The patient was not treated based on the original reported result. There was no adverse event. The lot number and expiration date of the ca reagent in use was requested, but the information was not provided by the customer. The field service representative found the ca cassette was not seated on the reagent platform correctly, which was damaging the reagent probes. He removed the affected cassette and replaced the splashguard. Calibration, precision on ca and qc were performed successfully by the customer.
Patient Sequence No: 1, Text Type: D, B5
[11251723]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11292826]
The affected cassette was returned for evaluation. Investigation of the cassette verified it does not sit properly in the reagent tray. It appeared that the cutout for the plastic conicle was not placed properly or not shaped properly. On further follow up, the customer was unaware of any further problems with calcium results.
Patient Sequence No: 1, Text Type: N, H10
[11458087]
After further investigation, a specific root cause could not be identified for this event. The issue may have been related to the reagent cassette or pre-analytical interference.
Patient Sequence No: 1, Text Type: N, H10
[19394845]
Further investigation determined that the reagent cassette was warped and likely bent the sample probes. This issue is currently under further investigation. However, the investigation concluded this issue occurred independently and after the occurrence of the erroneous results. The erroneous results were most likely caused by accumulation of debris or micro-clots may have clogged the sample probe, however this could not be confirmed with the information that was provided for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06736 |
| MDR Report Key | 3443358 |
| Report Source | 05,06 |
| Date Received | 2013-11-01 |
| Date of Report | 2014-05-09 |
| Date of Event | 2013-10-25 |
| Date Mfgr Received | 2013-10-25 |
| Date Added to Maude | 2013-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM GEN. 2 |
| Generic Name | TITRIMETRIC WITH EDTA AND INDIDICATOR, CALCIUM |
| Product Code | CHW |
| Date Received | 2013-11-01 |
| Model Number | NA |
| Catalog Number | 05061482190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-01 |