FDA Adverse Event Other Summary report: N

IMMULITE 2000

MDR report key: 1408900 · Received June 8, 2009

Report

Report Number: 2247117-2009-00019
Event Type: Other
Date Received: June 8, 2009
Date of Event: April 22, 2009
Report Date: May 27, 2009
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: DGC
PMA / PMN Number: K970227
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

USER ERROR: A SIEMENS HEALTHCARE TECHNICAL SUPPORT ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULTS WERE DUE TO THE OPERATOR RUNNING THE INSTRUMENT WITHOUT THE REQUIRED WATER SUPPLY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

DISCORDANT MULTIPLE ASSAY RESULTS WERE OBTAINED ON MULTIPLE PATIENTS SAMPLES. THE SAMPLES WERE REPEATED AND THE CORRECT RESULTS WERE REPORTED. PATIENT TREATMENT WAS PRESCRIBED FOR TWO PATIENTS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT RESULTS.

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Description of Event or Problem · 10

DISCORDANT MULTIPLE ASSAY RESULTS WERE OBTAINED ON MULTIPLE PATIENT'S SAMPLES. THE SAMPLES WERE REPEATED AND THE CORRECT RESULTS WERE REPORTED. PATIENT TREATMENT WAS PRESCRIBED FOR TWO PATIENTS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT RESULTS.

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Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IMMULITE 2000	IMMUNO-ASSAY ANALYZER	DGC	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1
10
11
12
13
14
15
16
17
18
19
2
20
21
22
23
24
25
26
27
28
29
3
30
31
32
33
34
35
36
37
38
39
4
40
41
42
43
44
45
5
6
7
8
9

PSUR Report

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Terms

Patient problem · 1

No Known Impact Or Consequence To Patient

Product problems · 1

Incorrect Or Inadequate Test Results

Remedial action · 1

Inspection

Source type · 2

Health Professional User facility

Type of report · 1

Initial submission

Seq	Age	Sex	Outcome	Treatment
1
10
11
12
13
14
15
16
17
18
19
2
20
21
22
23
24
25
26
27
28
29
3
30
31
32
33
34
35
36
37
38
39
4
40
41
42
43
44
45
5
6
7
8
9

Seq	Age	Sex	Outcome	Treatment
1
10
11
12
13
14
15
16
17
18
19
2
20
21
22
23
24
25
26
27
28
29
3
30
31
32
33
34
35
36
37
38
39
4
40
41
42
43
44
45
5
6
7
8
9

Seq	Age	Sex	Outcome	Treatment
1
10
11
12
13
14
15
16
17
18
19
2
20
21
22
23
24
25
26
27
28
29
3
30
31
32
33
34
35
36
37
38
39
4
40
41
42
43
44
45
5
6
7
8
9